FDA Structured Product Label as PDF

Transcription

BARE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
IVORY EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
PORCELAIN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
ALABASTER BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN- octinoxate, titanium dioxide cream
CREAMY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
SIMPLY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
SOFT BISQUE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
SAND EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
MEDIUM EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
SANDY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMANoctinoxate, titanium dioxide cream
DELICATE BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
TAN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN- octinoxate,
titanium dioxide cream
Merle Norman Cos metics , Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they
comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
---------Expert Finis h Makeup SPF 25
Active Ingredients
Purpose
Octinoxate 4.0%
Sunscreen
Titanium Dioxide 5.2%
Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin
cancer and early skin aging caused by the sun
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right
away
Stop use and ask a doctor if rash occurs
Warnings
For external use only
Do not use on damaged or broken skin
When using this product, keep out of eyes. Rinse with water to remove.
Directions
For sunscreen use
apply liberally and evenly 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
Sun Protection Meas ures . Spending time in the sun increases your risk of skin cancer and early skin
aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher
and other sun protection measures including:
limit time in the sun, especially from 10 a.m. -2 p.m.
wear long sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor
Inactive Ingredients
Isononyl Isononanoate, Ethylhexyl Palmitate, Polyethylene, Nylon-12, C12-15 Alkyl Benzoate, Lauroyl
Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Talc, Isostearyl Neopentanoate,
Astrocaryum Murumuru Seed Butter, Cetyl Dimethicone, Silica, Aluminum Starch Octenylsuccinate,
Copernicia Cerifera (Carnauba) Wax, Dimethicone, Tocopheryl Acetate, Polyhydroxystearic Acid,
Stearic Acid, Polyurethane-40, Sorbitan Oleate, Sorbitan Laurate, Myristyl Malate Phosphonic Acid,
BHT Aluminum Oxide, May Contain, Iron Oxides, Titanium Dioxide
Expert Finish Makeup Broad Spectrum SPF 25
Merle Norman
17 g Net Wt. .60 Oz
BARE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN
octinoxate, titanium dioxide cream
Product Information
Prod uct T yp e
HUMAN O TC DRUG
Route of Ad minis tration
TO PICAL
Ite m Cod e (S ource )
NDC:576 27-157
Active Ing redient/Active Moiety
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE (UNII: 4Y5P7MUD51) (O CTINO XATE - UNII:4Y5P7MUD51)
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIO XIDE - UNII:15FIX9 V2JP)
TITANIUM DIO XIDE
5.2 g in 10 0 g
Inactive Ing redients
Ing redient Name
Streng th
ISO NO NYL ISO NO NANO ATE (UNII: S4V5BS6 GCX)
ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )
HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)
NYLO N-12 (UNII: 446 U8 J0 75B)
C12 -15 ALKYL BENZO ATE (UNII: A9 EJ3J6 1HQ )
LAURO YL LYSINE (UNII: 113171Q 70 B)
TALC (UNII: 7SEV7J4R1U)
ISO STEARYL NEO PENTANO ATE (UNII: 411THY156 Q )
ASTRO CARYUM MURUMURU SEED BUTTER (UNII: 12V6 4UPU6 R)
CETYL DIMETHICO NE 2 5 (UNII: U4AS1BW4ZB)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O 6 29 4)
CARNAUBA WAX (UNII: R12CBM0 EIZ)
DIMETHICO NE (UNII: 9 2RU3N3Y1O )
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AO U0 F)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
SO RBITAN MO NO O LEATE (UNII: 0 6 XEA2VD56 )
SO RBITAN MO NO LAURATE (UNII: 6 W9 PS8 B71J)
PHO SPHO NIC ACID (UNII: 35V6 A8 JW8 E)
BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)
ALUMINUM O XIDE (UNII: LMI26 O 6 9 33)
FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)
Packag ing
#
Item Co de
Packag e Descriptio n
Marketing Start Date
Marketing End Date
Marke ting S tart Date
Marke ting End Date
1 NDC:576 27-157-0 2 1 in 1 CARTO N
1 NDC:576 27-157-0 1 17 g in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t
Marketing Information
Marke ting Cate gory
O TC mo no gra ph fina l
Ap p lication Numb e r or Monograp h Citation
pa rt352
10 /20 /20 13
IVORY EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 9
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
Streng th
NYLO N-12 (UNII: 446 U8 J0 75B)
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 9 -0 2 1 in 1 CARTO N
1 NDC:576 27-16 9 -0 1 17 g in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t
pa rt352
10 /20 /20 13
PORCELAIN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-159
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
Streng th
NYLO N-12 (UNII: 446 U8 J0 75B)
Packag ing
#
Item Co de
1 NDC:576 27-159 -0 2 1 in 1 CARTO N
1 NDC:576 27-159 -0 1 17 g in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t
Marketing End Date
pa rt352
Marke ting End Date
10 /20 /20 13
ALABASTER BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25
MERLE NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 0
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
NYLO N-12 (UNII: 446 U8 J0 75B)
Streng th
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 0 -0 2 1 in 1 CARTO N
pa rt352
10 /20 /20 13
CREAMY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25
MERLE NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 1
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
NYLO N-12 (UNII: 446 U8 J0 75B)
Streng th
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 1-0 2 1 in 1 CARTO N
1 NDC:576 27-16 1-0 1 17 g in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t
pa rt352
10 /20 /20 13
SIMPLY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25
MERLE NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 2
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
NYLO N-12 (UNII: 446 U8 J0 75B)
Streng th
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 2-0 2 1 in 1 CARTO N
pa rt352
10 /20 /20 13
SOFT BISQUE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 3
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
NYLO N-12 (UNII: 446 U8 J0 75B)
Streng th
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 3-0 2 1 in 1 CARTO N
pa rt352
10 /20 /20 13
SAND EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 4
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
Streng th
NYLO N-12 (UNII: 446 U8 J0 75B)
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 4-0 2 1 in 1 CARTO N
pa rt352
10 /20 /20 13
MEDIUM EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 5
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
Streng th
NYLO N-12 (UNII: 446 U8 J0 75B)
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 5-0 2 1 in 1 CARTO N
pa rt352
10 /20 /20 13
SANDY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE
NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 6
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
Streng th
NYLO N-12 (UNII: 446 U8 J0 75B)
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 6 -0 2 1 in 1 CARTO N
pa rt352
10 /20 /20 13
DELICATE BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25
MERLE NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 7
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
Streng th
NYLO N-12 (UNII: 446 U8 J0 75B)
Packag ing
#
Item Co de
1 NDC:576 27-16 7-0 2 1 in 1 CARTO N
Marketing End Date
pa rt352
Marke ting End Date
10 /20 /20 13
TAN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN
Product Information
Prod uct T yp e
HUMAN O TC DRUG
TO PICAL
NDC:576 27-16 8
Ing redient Name
Basis o f Streng th
Streng th
O CTINO XATE
4 g in 10 0 g
TITANIUM DIO XIDE
5.2 g in 10 0 g
Ing redient Name
NYLO N-12 (UNII: 446 U8 J0 75B)
Streng th
Packag ing
#
Item Co de
Marketing End Date
Marke ting End Date
1 NDC:576 27-16 8 -0 2 1 in 1 CARTO N
Labeler -
pa rt352
10 /20 /20 13
Merle Norman Cos metics , Inc (008479388)
Registrant -
Merle Norman Cos metics , Inc (008479388)
Establishment
Name
Me rle No rma n
Co sme tic s, Inc
Revised: 1/2016
Ad d re s s
ID/FEI
Bus ine s s Op e rations
0 0 8 479 38 8
ma nufa c ture (576 27-157, 576 27-16 9 , 576 27-159 , 576 27-16 0 , 576 27-16 1, 576 27-16 2, 576 2716 3, 576 27-16 4, 576 27-16 5, 576 27-16 6 , 576 27-16 7, 576 27-16 8 )
Merle Norman Cosmetics, Inc

FDA Structured Product Label as PDF

Transcription

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