Label: HYDRATION DYNAMICS MOISTURE REPLENISHMENT SPF 15- octinoxate octisalate oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-156-12, 68828-156-17, 68828-156-27, 68828-156-62 - 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 31, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INACTIVE INGREDIENT
OTHER INGREDIENTS: WATER/AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, PEG-8 BEESWAX/CERA ALBA, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CETYL ALCOHOL, CETETH-20, STEARETH-20, GLYCERIN, METHYLSILANOL MANNURONATE, HEMIDESMUS INDICUS EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, WITHANIA SOMNIFERIA EXTRACT, BUTYLENE GLYCOL, SACCHARIDE ISOMERATE, SODIUM PCA, SODIUM HYALURONATE, TREHALOSE, POLYQUATERNIUM-51, UREA, GLYCERYL STEARATE, HYDROGENATED AVOCADO OIL, DIMETHICONE, DIMETHICONE CROSSPOLYMER, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, PROPYLENE GLYCOL, CODIUM TOMENTOSUM EXTRACT, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, FRAGRANCE/PARFUM, ACRYLATES COPOLYMER, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, BIOSACCHARIDE GUM-4, PANTHENOL, TOCOPHERYL ACETATE, TRISODIUM EDTA, GLYCINE SOYA (SOYBEAN) SEED EXTRACT, CERAMIDE 3, GLYCERYL POLYMETHACRYLATE, PALMITOYL OLIGOPEPTIDE, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, RED 33/CI 17200, BLUE 1/CI 42090 [FRAGRANCE/PARFUM CONTAINS: CINNAMYL ALCOHOL, HYDROXYCITRONELLAL, BENZYL SALICYLATE, HYDROXYISOHEXYL 3-CYCLOHEXANE CARBOXALDEHYDE (LYRAL), BENZYL BENZOATE, CITRONELLOL, ALPHA-ISOMETHYL IONONE]
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATION DYNAMICS MOISTURE REPLENISHMENT SPF 15
octinoxate octisalate oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-156 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) SACCHARIDE ISOMERATE (UNII: W8K377W98I) LAURETH-7 (UNII: Z95S6G8201) CETYL ALCOHOL (UNII: 936JST6JCN) CETETH-20 (UNII: I835H2IHHX) STEARETH-20 (UNII: L0Q8IK9E08) HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DMDM HYDANTOIN (UNII: BYR0546TOW) SHEA BUTTER (UNII: K49155WL9Y) CHONDRUS CRISPUS (UNII: OQS23HUA1X) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) PEG-4 LAURATE (UNII: AYF4VM3N1Z) GLYCERIN (UNII: PDC6A3C0OX) METHYLSILANOL ASCORBATE (UNII: 46Z5D1I0IS) WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TREHALOSE (UNII: B8WCK70T7I) POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G) UREA (UNII: 8W8T17847W) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) AVOCADO OIL (UNII: 6VNO72PFC1) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CODIUM TOMENTOSUM (UNII: B8B45BRU87) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) EDETATE TRISODIUM (UNII: 420IP921MB) SOYBEAN SEED OIL (UNII: P6C7NVO1UF) CERAMIDE 3 (UNII: 4370DF050B) GLYCERYL 1-ADIPATE (UNII: 6UXO8KCR3J) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) GINGER (UNII: C5529G5JPQ) LEVOMENOL (UNII: 24WE03BX2T) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-156-12 1 in 1 BOX 1 NDC:68828-156-62 50 mL in 1 JAR 2 NDC:68828-156-27 1 in 1 BOX 2 NDC:68828-156-17 7 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/24/2012 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
