Label: CACTUS WHITENING SUN SPF 34 PA PLUS PLUS FOR MEN- octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-032-01 - 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 October 3, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
WATER, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, ARBUTIN, CETEARETH-6 OLIVATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, C14-22 ALCOHOLS, CYCLOPENTASILOXANE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, SORBITAN STEARATE, C12-20 ALKYL GLUCOSIDE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, ISOHEXADECANE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER, POLYSORBATE 80, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, STEARIC ACID, BHT, TOCOPHERYL ACETATE, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CACTUS WHITENING SUN SPF 34 PA PLUS PLUS FOR MEN
octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-032 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.9 mL in 70 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.5 mL in 70 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 0.65 mL in 70 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ARBUTIN (UNII: C5INA23HXF) C14-22 ALCOHOLS (UNII: B1K89384RJ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) PHENOXYETHANOL (UNII: HIE492ZZ3T) CUCUMBER (UNII: YY7C30VXJT) METHYLPARABEN (UNII: A2I8C7HI9T) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-032-01 70 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