Label: RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS- octinoxate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-037-01 - Packager: SKINFOOD CO., LTD.
- 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 October 9, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Talc, Mica (CI 77019), Methyl Methacrylate Crosspolymer, Silica, Nylon-12, Ethylene/Acrylic Acid Copolymer, Methylene Bis-Benzotriazolyl Tetramethylbutylpheno, Trimethylolpropane Triethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Dimethicone, Aluminum Hydroxide, Methylparaben, MethiconeDimethicone/Methicone Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Fragrance(Parfum), Propylparaben, Iron Oxides (CI 77499), Citrus Aurantium Dulcis (Orange) Fruit Extract, Caprylic/Capric Triglyceride, Solanum Lycopersicum (Tomato) Fruit Oil, Water - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS
octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-037 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.66 g in 9.5 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 0.29 g in 9.5 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE 0.27 g in 9.5 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MAGNESIUM MYRISTATE (UNII: Z1917F0578) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ORANGE (UNII: 5EVU04N5QU) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TOMATO (UNII: Z4KHF2C175) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-037-01 9.5 g in 1 CARTON 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