MOISTURIZING 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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MOISTURIZING 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 PALMITATE, ISOPROPYL ISOSTEARATE, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, SILICA, DI-PPG-3 MYRISTYL ETHER ADIPATE, GLYCERYL STEARATE, STEARIC ACID, SACCHARIDE ISOMERATE, POLYSORBATE 20, LECITHIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, POLYSILICONE-11, LAURETH-12, CYCLOPENTASILOXANE, ACRYLATES/DIMETHICONE COPOLYMER, METHYLSILANOL MANNURONATE, DMDM HYDANTOIN, TRIHYDROXYSTEARIN, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TETRASODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, BORAGO OFFICINALIS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ALGAE EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891]  [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]

MOISTURIZING MAKEUP WITH SPF 15

TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN.

CLINICALLY, ALLERGY AND IRRITANCY TESTED.

JAFRA

MOISTURIZING MAKEUP SPF 15

30 ML / 1 FL OZ

Moisturizing Make-up_Box-1

Moisturizing Make-up_Box-2
Moisturizing Make-up_Box-3
MOISTURIZING MAKEUP  SPF 15
octinoxate octisalate oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-048
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 PALMITATE (UNII: 8CRQ2TH63M)  
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
LAURETH-12 (UNII: OAH19558U1)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PANTHENOL (UNII: WV9CM0O67Z)  
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
MUNG BEAN (UNII: 1LIB31N73G)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BORAGE (UNII: PB618V0K2W)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
JOJOBA OIL (UNII: 724GKU717M)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SHEA BUTTER (UNII: K49155WL9Y)  
METHYLSILANOL ACETYLMETHIONATE (UNII: FKT0KP5RFC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-048-111 in 1 BOX
1NDC:68828-048-6730 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Revised: 5/2012
Document Id: c0aa639c-80e2-4ee9-bdff-20156248716a
Set id: b7777bf9-cefb-4d24-b8ca-d4352f22c0ca
Version: 1
Effective Time: 20120501
 
JAFRA COSMETICS INTERNATIONAL