Label: BETULA ALBA JUICE BB SPF 30 PA PLUS PLUS FOR MEN- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-036-01 - 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:
Water, Betula Platyphylla Japonica Juice, 4-Methylbenzylidene Camphor, Propylene Glycol, Butylene Glycol, Arbutin, Silica, Cetyl Alcohol, Cetyl Ethylhexanoate, Stearic Acid, Palmitic Acid, Polysorbate 60, Sorbitan Sesquioleate, Glyceryl Stearate, Tocopheryl Acetate, Dimethicone, Adenosine, Lecithin, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Propylene Glycol Laurate, Polyacrylate-13, Polyisobutene, Sorbitan Isostearate, BHT, Triethanolamine, Propylparaben, Butylparaben, Methylparaben, Phenoxyethanol, CI 77491, CI 77492, CI 77499 - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BETULA ALBA JUICE BB SPF 30 PA PLUS PLUS FOR MEN
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-036 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 g in 50 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 2 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARBUTIN (UNII: C5INA23HXF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL ALCOHOL (UNII: 936JST6JCN) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) ADENOSINE (UNII: K72T3FS567) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSORBATE 20 (UNII: 7T1F30V5YH) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-036-01 50 g 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