Label: CALM DYNAMICS GENTLE HYDRATING DAY SPF 15- octinoxate octisalate oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-155-12, 68828-155-62 - 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
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INACTIVE INGREDIENT
OTHER INGREDIENTS: WATER/AQUA, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, TRIDECYL NEOPENTANOATE, ALUMINUM STARCH OCTENYLSUCCINATE, SACCHARIDE ISOMERATE, BUTYLENE GLYCOL, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LURETH-7, HEMIDESMUS INDICUS EXTRACT, PHYLLANTHUS EMBLICA EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, DIMETHICONE, PUERARIA LOBATA ROOT EXTRACT, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID.
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CALM DYNAMICS GENTLE HYDRATING DAY SPF 15
octinoxate octisalate oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-155 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 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) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SACCHARIDE ISOMERATE (UNII: W8K377W98I) OAT (UNII: Z6J799EAJK) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) 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) PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-155-12 1 in 1 BOX 1 NDC:68828-155-62 50 mL in 1 JAR 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
