SKIN DEFENSE MAKEUP SPF-15- octinoxate octisalate oxybenzone lotion 
JAFRA COSMETICS INTERNATIONAL

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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SKIN DEFENSE MAKEUP SPF-15

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL ISOSTEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, STEARIC ACID, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE,  LECITHIN, POLYETHYLENE, METHYL METHACRYLATE COPOLYMER, SILICA, DIMETHICONE, SODIUM HYALURONATE, TREHALOSE, SODIUM PCA, POLYQUATERNIUM-51, UREA, GLYCERIN, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYSORBATE 20, TRIETHANOLAMINE, TAGETUS ERECTA (AFRICAN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, PROPYLENE GLYCOL, MACROCYSTIS PYRIFERA EXTRACT,  HYDROLYZED WHEAT PROTEIN, PVP, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, FRAGRANCE/PARFUM, PANTHENOL, TOCOPHERYL ACETATE, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA [MAY CONTAIN, +/-: TITANIUM DIOXIDE/CI 77891, IRON OXIDES/CI 77491/CI 77492/CI 77499]  [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, ALPHA-ISOMETHYL IONONE, GERANIOL, LIMONENE, LINALOOL].

SPF 15 PROTECTS AGAINST DAMAGING ULTRAVIOLET RAYS. MATTE FINISH. SHEER TO MEDIUM COVERAGE.

TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN.

JAFRA

SKIN DEFENSE MAKEUP SPF 15

Skin Defense MU SPF-15_ART_Box_30mLSkin Defense MU SPF-15_ART_LBL-FR_30mLSkin Defense MU SPF-15_ART_LBL-BK_30mLSkin Defense MU SPF-15_ART_Tester Box-FRSkin Defense MU SPF-15_ART_Tester Box-BK

SKIN DEFENSE MAKEUP  SPF-15
octinoxate octisalate oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-147
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
METHYL METHACRYLATE (UNII: 196OC77688)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TREHALOSE (UNII: B8WCK70T7I)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)  
UREA (UNII: 8W8T17847W)  
GLYCERIN (UNII: PDC6A3C0OX)  
OAT (UNII: Z6J799EAJK)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TROLAMINE (UNII: 9O3K93S3TK)  
TAGETES ERECTA FLOWER (UNII: UH5X33P33E)  
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
POVIDONE K30 (UNII: U725QWY32X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-147-111 in 1 BOX
1NDC:68828-147-6730 mL in 1 BOTTLE
2NDC:68828-147-1010 in 1 BOX
2NDC:68828-147-178 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/24/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture

Revised: 5/2012
Document Id: 9f38acf2-5ebc-4c2a-83b6-2813563edcc3
Set id: 9b4dfd5a-afdc-4fd6-8eff-bdc7cfdf65dd
Version: 2
Effective Time: 20120523
 
JAFRA COSMETICS INTERNATIONAL