ULTRA COLOR RICH MEGA IMPACT - octinoxate, 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.

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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

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ULTRA COLOR RICH  MEGA IMPACT
octinoxate, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0188
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE150 mg  in 3 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE90 mg  in 3 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0188-13 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/22/2009
Labeler - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Products, Inc.001807106manufacture

Revised: 12/2009
Document Id: ae64975b-ac6a-45b7-831c-4c003032bcca
Set id: 7a906a9d-2b3e-4119-ad62-30d68c50850a
Version: 1
Effective Time: 20091222
 
Avon Products, Inc.