OTC Medication Information: Ultra Color Rich Cool Bliss

ULTRA COLOR RICH COOL BLISS — 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 7.0%

INACTIVE INGREDIENTS/ INGRÉDIENTS INACTIFS:
WATER/EAU, DIISOPROPYL DIMER DILINOLEATE,
GLYCERYL TRIACETYL HYDROXYSTEARATE, SIMMONDSIA
CHINENSIS (JOJOBA) SEED OIL, POLYETHYLENE,
LANOLIN, POLYGLYCERYL-3 DIISOSTEARATE,
STEARYL HEPTANOATE, C10-30 CHOLESTEROL/
LANOSTEROL ESTERS, OZOKERITE, PHENYL TRIMETHICONE,
LAURYL PEG/PPG-18/18 METHICONE,
BARIUM SULFATE, CALCIUM SODIUM BOROSILICATE,
DIGLYCERIN, PARFUM/FRAGRANCE, NYLON-12, SORBITAN
SESQUIOLEATE, MICROCRYSTALLINE WAX/
CIRE MICROCRISTALLINE, CAPRYLYL GLYCOL, PENTYLENE
GLYCOL, POLYGLYCERYL-10 HYDROXYSTEARATE/
STEARATE/EICOSADIOATE, MENTHYL PCA,
METHYL DIISOPROPYL PROPIONAMIDE, XYLITYLGLUCOSIDE,
DISODIUM EDTA, ANHYDROXYLITOL, GLYCERIN,
POLYGLYCERIN-3, TOCOPHERYL ACETATE, ISOPROPYL
TITANIUM TRIISOSTEARATE, XYLITOL, SUCRALOSE,
DIMETHICONE, MENTHA PIPERITA (PEPPERMINT)
OIL, DEXTRIN PALMITATE, TIN OXIDE, SORBITAN
STEARATE, PEG-40 STEARATE, TOCOPHEROL,
SILICA. MAY CONTAIN/PEUT CONTENIR: TITANIUM
DIOXIDE/CI 77891, MICA/CI 77019, IRON OXIDES,
RED 7 LAKE/CI 15850, RED 33 LAKE/CI 17200,
YELLOW 5 LAKE/CI 19140, RED 6 LAKE/CI 15850,RED 27 LAKE/CI 45410, YELLOW 6 LAKE/CI 15985.

image of label
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image of label
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ULTRA COLOR RICH COOL BLISS octinoxate lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0191
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 210 mg in 3 g
Inactive Ingredients
Ingredient Name Strength
WATER
LANOLIN
PHENYL TRIMETHICONE
BARIUM SULFATE
SORBITAN SESQUIOLEATE
CAPRYLYL GLYCOL
PENTYLENE GLYCOL
GLYCERIN
XYLITOL
SUCRALOSE
DIMETHICONE
TITANIUM DIOXIDE
MICA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10096-0191-1 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 12/29/2009
Labeler — Avon Products, Inc. (001468693)
Establishment
Name Address ID/FEI Operations
Avon Products, Inc. 001807106 manufacture

Revised: 12/2009 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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