Label: SPF 15 SELF TANNER- octinoxate,oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76224-101-01, 76224-101-02 - Packager: Whish Body Holdings Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 1, 2011
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ACTIVE INGREDIENT
Active ingredients
Octinoxate 7.5 %
Oxybenzone 5.0%
stop use and ask a doctor if rash or irritation develops and lasts.
avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water.
Water ( aqua), aloe barbadensis ( aloe vera) leaf juice, C12-15 alkyl benzoate, dihydroxyacetone, glycerin, caprylic/ capric triglyceride, polysorbate-60, hydroxyethyl acrylates/ sodium acryloyl dimothyl taurate copolymer, glyceryl stearate , tocopheryl acetate, retinyl palmitate, punica granatum ( pomegranate) extract, phospholipids, panthenol, mangifora indica (mango) seed butter,lyceum barbarum ( goji berry) fruit extract,
glycynhiza glabra extract, coffea Arabica (coffee) seed, chamimilla recutita matricaria ( chamomile) leaf extract, butyrospermum parkii (shea butter), ascorbyl palmitate, cocos nucifera( cocout) oil, allantoin ,phenoxyethanol, ethylhexylglycerin, benzyl alcohol, xanthan gum, algae (seaweed) extract, pulmonaria officinalis extract, quillaja saponaria ( soap bark) extract, kigelia Africana fruit extract, rosmainus officinalis ( rosemary) leaf extract, fragrance ( parfum), citric acid,
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 15 SELF TANNER
octinoxate,oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76224-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIHYDROXYACETONE (UNII: O10DDW6JOO) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYSORBATE 60 (UNII: CAL22UVI4M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POMEGRANATE (UNII: 56687D1Z4D) PANTHENOL (UNII: WV9CM0O67Z) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) ARABICA COFFEE BEAN (UNII: 3SW678MX72) SHEA BUTTER (UNII: K49155WL9Y) COCONUT OIL (UNII: Q9L0O73W7L) ALLANTOIN (UNII: 344S277G0Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BENZYL ALCOHOL (UNII: LKG8494WBH) XANTHAN GUM (UNII: TTV12P4NEE) ROSEMARY (UNII: IJ67X351P9) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRAL (UNII: T7EU0O9VPP) GERANIOL (UNII: L837108USY) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76224-101-02 1 in 1 BOX 1 NDC:76224-101-01 150 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/25/2011 Labeler - Whish Body Holdings Inc (787524136) Registrant - GAR Laboratories (074933615) Establishment Name Address ID/FEI Business Operations GAR Laboratories 074933615 manufacture
