Label: PEACH SAKE SUN SPF32 PA PLUS PLUS- octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-012-01 - Packager: SKINFOOD CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 7, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
WATER, ISOAMYL p-METHOXYCINNAMATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, POLYSORBATE 80, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, RIMETHOXYCAPRYLYLSILANE, SORBITAN LAURATE, ALUMINUM HYDROXIDE, STEARIC ACID, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, DIMETHICONE, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CARBOMER, BHT, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, TRIETHANOLAMINE, DISODIUM EDTA, RICE FERMENT FILTRATE (SAKE), PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEACH SAKE SUN SPF32 PA PLUS PLUS
octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-012 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.25 mL in 75 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 2.47 mL in 75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ISOHEXADECANE (UNII: 918X1OUF1E) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PEACH (UNII: 3OKE88I3QG) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHAMOMILE (UNII: FGL3685T2X) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CENTELLA ASIATICA (UNII: 7M867G6T1U) SOYBEAN (UNII: L7HT8F1ZOD) APPLE (UNII: B423VGH5S9) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-012-01 75 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2011 Labeler - SKINFOOD CO., LTD. (690324173) Registrant - SKINFOOD CO., LTD. (690324173) Establishment Name Address ID/FEI Business Operations SKINFOOD CO., LTD. 690324173 manufacture