Label: JAFRA PRO FACE LIFT SPF 20- octocrylene octisalate homosalate avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-049-11, 68828-049-67 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 14, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INACTIVE INGREDIENT
INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, SORBITAN LAURATE, HYDROXYETHYLCELLULOSE, ACETYL DIPEPTIDE-1, CETYL ESTER, PENTYLENE GLYCOL, CETEARYL ALCOHOL, COCO-GLUCOSIDE, ALGAE EXTRACT, PULLULAN, NIACINAMIDE, HYDROLYZED SOY PROTEIN, ZEA MAYS (CORN) KERNEL EXTRACT, XANTHAN GUM, SODIUM HYALURONATE, TREHALOSE, SODIUM PCA, POLYQUATERNIUM-51, UREA, GLYCERIN, AVENA SATIVA (OAT) KERNEL EXTRACT, COCOS NUCIFERA (COCONUT) OIL, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, SANTALUM ALBUM (SANDALWOOD) WOOD EXTRACT, ROSE EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, PASSIFLORA INCARNATA FRUIT EXTRACT, PRUNUS ARMENIACA (APRICOT) FRUIT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, CANANGA ODORATA FLOWER EXTRACT, CUCUMIS MELO CANTALUPENSIS FRUIT EXTRACT, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, CAPRYLIC/CAPRIC TRIGLYCERIDES, ALARIA ESCULENTA EXTRACT, YEAST AMINO ACIDS, TRICALCIUM PHOSPHATE, MORINDA CITRIFOLIA EXTRACT, CARICA PAPAYA EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, PICHIA ANOMALA EXTRACT, TRIPLEUROSPERMUM MARITIMA EXTRACT, ALUMINUM STARCH OCTENYLSUCCINATE, LAUROYL LYSINE, MICROCRYSTALLINE CELLULOSE, CELLULOSE GUM, DIPOTASSIUM GLYCYRRHIZATE, GLYCINE SOYA (SOYBEAN) OIL, ARNICA MONTANA FLOWER EXTRACT, TOCOPHEROL, DMDM HYDANTOIN, HYDROGENATED LECITHIN, PANTHENOL, TRIETHANOLAMINE, TRISODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, MENTHYL LACTATE, BENZYLIDENE DIMETHOXYDIMETHYLINDANONE, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7.
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
- WARNINGS
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INGREDIENTS AND APPEARANCE
JAFRA PRO FACE LIFT SPF 20
octocrylene octisalate homosalate avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-049 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) N-ACETYL DIPEPTIDE-1 (UNII: HA41Z1UF8D) CETYL ESTERS WAX (UNII: D072FFP9GU) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO GLUCOSIDE (UNII: ICS790225B) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) PULLULAN (UNII: 8ZQ0AYU1TT) NIACINAMIDE (UNII: 25X51I8RD4) SOY PROTEIN (UNII: R44IWB3RN5) CORN (UNII: 0N8672707O) XANTHAN GUM (UNII: TTV12P4NEE) 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) COCONUT OIL (UNII: Q9L0O73W7L) CUCUMBER JUICE (UNII: 61845009SP) SANDALWOOD (UNII: 3641YW25N2) ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13) APPLE JUICE (UNII: 9871T0PD5P) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) APRICOT JUICE (UNII: YX3B7ZG375) RASPBERRY JUICE (UNII: 427AYI9PDE) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) MUSKMELON (UNII: ZV095H5633) C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) C20-22 ALCOHOLS (UNII: O4M0347C6A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALARIA ESCULENTA (UNII: EJ9JK8J58D) YEAST (UNII: 3NY3SM6B8U) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5) PAPAYA JUICE (UNII: AZ5XLY17KM) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) PICHIA JADINII (UNII: 8JRL032K80) BETA VULGARIS POLLEN (UNII: W7NU4B5CIY) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) LAUROYL LYSINE (UNII: 113171Q70B) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SOYBEAN OIL (UNII: 241ATL177A) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) TOCOPHEROL (UNII: R0ZB2556P8) DMDM HYDANTOIN (UNII: BYR0546TOW) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) PANTHENOL (UNII: WV9CM0O67Z) TROLAMINE (UNII: 9O3K93S3TK) EDETATE TRISODIUM (UNII: 420IP921MB) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-049-11 1 in 1 BOX 1 NDC:68828-049-67 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/04/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture
