Ultra Color Rich Mega Impact (Octinoxate, Oxybenzone) Lipstick [Avon Products, Inc.] -

ULTRA COLOR RICH MEGA IMPACT (OCTINOXATE, OXYBENZONE) LIPSTICK [AVON PRODUCTS, INC.]
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NDC	10096-0188-1
Set ID	7a906a9d-2b3e-4119-ad62-30d68c50850a
Category	HUMAN OTC DRUG LABEL
Packager	Avon Products, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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DOSAGE & ADMINISTRATION

DIRECTIONS: Apply liberally before sun
exposure and as needed.
WARNINGS

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

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

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

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
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	150 mg in 3 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	90 mg in 3 g

Ingredient Name	Strength
Inactive Ingredients
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
UREA (UNII: 8W8T17847W)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETA CAROTENE (UNII: 01YAE03M7J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10096-0188-1	3 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/22/2009

Labeler - Avon Products, Inc. (001468693)

Name	Address	ID/FEI	Business Operations
Establishment
Avon Products, Inc.		001807106	manufacture

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Medic

ULTRA COLOR RICH MEGA IMPACT (OCTINOXATE, OXYBENZONE) LIPSTICK [AVON PRODUCTS, INC.]

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