OTC Medication Information: Ultra Color Rich Moisture Seduction

ULTRA COLOR RICH MOISTURE SEDUCTION- octinoxate lipstick
Avon Products, 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.

DIRECTIONS: Apply liberally
before sun exposure and as needed.

WARNING: Discontinue
use if skin irritation develops or
increases. If irritation persists,
consult a health care practitioner.

Uses: Helps prevent sunburn. Higher SPF
gives more sunburn protection.

ACTIVE INGREDIENT/INGRÉDIENT ACTIF:
OCTINOXATE 7.5%

INACTIVE INGREDIENTS/INGRÉDIENTS INACTIFS:
DIISOSTEARYL FUMARATE, BARIUM SULFATE,SQUALANE, POLYBUTENE, DIISOPROPYL DIMER DILINOLEATE,
OZOKERITE, MICROCRYSTALLINE WAX/
CIRE MICROCRISTALLINE, POLYGLYCERYL-2 DIISOSTEARATE,
LANOLIN, POLYETHYLENE, DI-C12-15
ALKYL FUMARATE, PETROLATUM, CALCIUM SODIUM
BOROSILICATE, ZEA MAYS (CORN) STARCH, ISOPROPYL
ISOSTEARATE, STEARYL/PPG-3 MYRISTYL ETHER
DIMER DILINOLEATE, SUCROSE ACETATE ISOBUTYRATE,
CETYL ALCOHOL, SYNTHETIC FLUORPHLOGOPITE,
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,
ALOE BARBADENSIS LEAF EXTRACT, GLYCINE SOJA
(SOYBEAN) OIL, RETINOL, HONEY EXTRACT/EXTRAIT
DE MIEL, HYDROLYZED SILK, BIOTIN/FOLIC ACID/
CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC
ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST
POLYPEPTIDES, TAMARINDUS INDICA SEED EXTRACT,
PORTULACA OLERACEA EXTRACT, PHENYL TRIMETHICONE,
POLYMETHYLSILSESQUIOXANE, CHOLESTERYL/
BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE,
SILICA, TOCOPHERYL ACETATE, GLYCERIN,
CAPRYLYL GLYCOL, HYDROGENATED CASTOR OIL, BEHENYL
ERUCATE, ALLANTOIN, ALLYL METHACRYLATES
CROSSPOLYMER, ISOPROPYL TITANIUM TRIISOSTEARATE,
LECITHIN, ACRYLATES COPOLYMER,
PARFUM/ FRAGRANCE, BEESWAX/CIRE D’ABEILLE,
PEG-80 SORBITAN LAURATE, ACRYLATES/CARBAMATE
COPOLYMER, CALCIUM PCA, ETHYLENE/PROPYLENE/
STYRENE COPOLYMER, C12-15 ALKYL BENZOATE,
HYALURONIC ACID, WATER/EAU, COLLAGEN, ETHYLHEXYL
PALMITATE, HYDROXYETHYL UREA, TRIBEHENIN,
BUTYLENE/ETHYLENE/STYRENE COPOLYMER,
RETINYL PALMITATE, LAUROYL LYSINE, PENTYLENE
GLYCOL, SORBITAN ISOSTEARATE, UREA, PHENOXYETHANOL,
ASCORBYL PALMITATE, BETA-CAROTENE,
PALMITOYL OLIGOPEPTIDE. MAY CONTAIN/PEUT CONTENIR:
MICA/CI 77019, BISMUTH OXYCHLORIDE/CI
77163, TITANIUM DIOXIDE/CI 77891, IRON OXIDES/CI
77489/CI77491/CI 77492/CI 77499, RED 7 LAKE/
C15850, YELLOW 5 LAKE/CI 19140, RED 33 LAKE/CI
17200, RED 6/CI 15850, CARMINE/CI 75470, BLUE 1
LAKE/CI 42090, ORANGE 5/CI 45370, RED 21 LAKE/CI
45380, RED 21/CI 45380, RED 22 LAKE/CI 45380, RED
27 LAKE/CI 45410, RED 28 LAKE/CI 45410, RED 30
LAKE/CI 73360, YELLOW 10 LAKE/CI 47005, YELLOW6 LAKE/CI 15985, RED 40 LAKE/CI 16035.

PDP
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image of label
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ULTRA COLOR RICH MOISTURE SEDUCTION octinoxate lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0229
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.225 g in 3 g
Inactive Ingredients
Ingredient Name Strength
SQUALANE
MICROCRYSTALLINE WAX
LANOLIN
PETROLATUM
SUCROSE ACETATE ISOBUTYRATE
CETYL ALCOHOL
RETINOL
PHENYL TRIMETHICONE
GLYCERIN
CAPRYLYL GLYCOL
HYDROGENATED CASTOR OIL
ALLANTOIN
C12-15 ALKYL BENZOATE
HYALURONIC ACID
WATER
ETHYLHEXYL PALMITATE
HYDROXYETHYL UREA
TRIBEHENIN
LAUROYL LYSINE
PENTYLENE GLYCOL
UREA
PHENOXYETHANOL
ASCORBYL PALMITATE
BETA CAROTENE
PALMITOYL OLIGOPEPTIDE
MICA
BISMUTH OXYCHLORIDE
TITANIUM DIOXIDE
BARIUM SULFATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10096-0229-1 3 g in 1 CASE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/14/2010
Labeler — Avon Products, Inc. (001468693)

Revised: 12/2010 Avon Products, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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