OTC Medication Information: Ultra Color Rich Mega Impact

ULTRA COLOR RICH MEGA IMPACT — octinoxate and oxybenzone 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.

ACTIVE INGREDIENTS/INGRÉDIENTS
ACTIFS: OCTINOXATE 5.0 %,
OXYBENZONE 3.0%.

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

INACTIVE INGREDIENTS / INGRÉDIENTS
INACTIFS: DIISOPROPYL DIMER DILINOLEATE
POLYGLYCERYL-2 DIISOSTEARATE
LANOLIN
PETROLATUM
POLYBUTENE
STEARYL/PPG-3 MYRISTYL ETHER DIMER DILINOLEATE
SUCROSE ACETATE ISOBUTYRATE
MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE
POLYETHYLENE
OZOKERITE
CERESIN
PHENYL TRIMETHICONE
POLYMETHYLSILSESQUIOXANE
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
CALCIUM SODIUM BOROSILICATE
BARIUM SULFATE
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE
SILICA
TOCOPHERYL ACETATE
ALLANTOIN
ETHYLENE/PROPYLENE/STYRENE COPOLYMER
ACRYLATES COPOLYMER
PARFUM/FRAGRANCE
ALLYL METHACRYLATES CROSSPOLYMER
WATER/EAU
LECITHIN
C12-15 ALKYL BENZOATE
HYDROXYETHYL UREA
BUTYLENE/ETHYLENE/STYRENE COPOLYMER
TIN OXIDE
PENTYLENE GLYCOL
HYDROLYZED SILK
TAMARINDUS INDICA SEED EXTRACT
RETINYL PALMITATE
UREA
ASCORBYL PALMITATE
BETA-CAROTENE
MAY CONTAIN:
MICA/CI 77019
IRON OXIDES
TITANIUM DIOXIDE/CI 77891
RED 33 LAKE/CI 17200
RED 7 LAKE
RED 6/CI 15850
RED 6 LAKE/CI 15850
BISMUTH OXYCHLORIDE/CI 77163
BLUE 1 LAKE/CI 42090
CARMINE/CI 75470
YELLOW 5 LAKE/CI 19140
YELLOW 6 LAKE
YELLOW 10 LAKE/CI 47005
RED 7/CI 15850
RED 28 LAKE/CI 45410
RED 36/CI 12085
RED 40 LAKE/CI 16035
ORANGE 5/CI 45370
RED 21/CI 45380
RED 22 LAKE/CI 45380
RED 27 LAKE/CI 45410
RED 30 LAKE/CI 73360

image of label
(click image for full-size original)
image of label
(click image for full-size original)

ULTRA COLOR RICH MEGA IMPACT octinoxate, oxybenzone lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0188
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 150 mg in 3 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 90 mg in 3 g
Inactive Ingredients
Ingredient Name Strength
LANOLIN
PETROLATUM
PHENYL TRIMETHICONE
BARIUM SULFATE
ALLANTOIN
WATER
C12-15 ALKYL BENZOATE
PENTYLENE GLYCOL
UREA
ASCORBYL PALMITATE
BETA CAROTENE
MICA
TITANIUM DIOXIDE
BISMUTH OXYCHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10096-0188-1 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 12/22/2009
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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