Label: HARMONY DYNAMICS FACIAL BOOSTING SPF 15- octinoxate octisalate oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-163-12, 68828-163-62 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
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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- ACTIVE INGREDIENT
- PURPOSE
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INACTIVE INGREDIENT
INGREDIENTS: WATER/AQUA, CETEARYL ALCOHOL, CETEARETH-20, GLYCERIN, STEARYL STEARATE, MYRISTYL MYRISTATE, GARCINIA INDICA SEED BUTTER, SODIUM PCA, CYCLOMETHICONE, DIMETHICONOL, PENTYLENE GLYCOL, BIS-DIGLYCERYL POLYACRYLADIPATE-2, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, CASTANEA SATIVA (CHESTNUT) EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, MORINGA OLIEFERA EXTRACT, VETIVERA ZINZANOIDS (KHUS ROOT) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, MENTHA PIPERTITA (PEPPERMINT) EXTRACT, CERAMIDE 2, PEG 10 BRASSICA CAMESTRIS STEROL, PALMITOYL OLIGOPEPTIDE, C12-15 ALKYL BENZOATE, TRIBEHENIN, CETYL ALCOHOL, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, TOCOPHEROL, GLYCEINE SOJA (SOYBEAN) ISOFLAVONE AGLYONE, LECITHIN, POLYSORBATE 80, ALCOHOL, FRAGRANCE/PARFUM, TRIETHANOLAMINE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DMDM HYDANTOIN, PANTHENOL, BIOSACCHARIDE GUM-4, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, PEG-4 LAURATE, IODOPROPYL BUTYLCARBAMATE, TRISODIUM EDTA.
- DESCRIPTION
- INDICATIONS & USAGE
- INSTRUCTIONS FOR USE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HARMONY DYNAMICS FACIAL BOOSTING SPF 15
octinoxate octisalate oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-163 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) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERIN (UNII: PDC6A3C0OX) STEARYL STEARATE (UNII: 5WX2EGD0DK) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) CYCLOMETHICONE (UNII: NMQ347994Z) DIMETHICONOL (250000 MW) (UNII: RKI3S914RT) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIGLYCERIN (UNII: 3YC120743U) SHEA BUTTER (UNII: K49155WL9Y) SPANISH CHESTNUT (UNII: 2MT5XMR2YW) LICORICE (UNII: 61ZBX54883) MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B) VETIVERIA ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z) WITHANIA SOMNIFERA LEAF (UNII: J337CNM3CW) PEPPERMINT (UNII: V95R5KMY2B) CERAMIDE 2 (UNII: C04977SRJ5) CAMPESTEROL (UNII: 5L5O665639) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIBEHENIN (UNII: 8OC9U7TQZ0) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN (UNII: L7HT8F1ZOD) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) DMDM HYDANTOIN (UNII: BYR0546TOW) PANTHENOL (UNII: WV9CM0O67Z) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) CHONDRUS CRISPUS (UNII: OQS23HUA1X) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-163-12 1 in 1 BOX 1 NDC:68828-163-62 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 04/19/2012 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