Label: REGENERATION WRINKLE CONTROL CREAM SPF 15- avobenzone, homosalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57975-161-01, 57975-161-02 - Packager: BeautiControl
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated February 5, 2016
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS AND PRECAUTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGENERATION WRINKLE CONTROL CREAM SPF 15
avobenzone, homosalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57975-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 55.84 g in 100 g TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) 0.097 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 3.09 g in 100 g XANTHAN GUM (UNII: TTV12P4NEE) 0.4 g in 100 g XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) 1.01 g in 100 g XYLITOL (UNII: VCQ006KQ1E) 0.81 g in 100 g CREATININE (UNII: AYI8EX34EU) 0.5 g in 100 g SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 0.25 g in 100 g STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 2.4 g in 100 g TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D) 1.2 g in 100 g POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91) 2.12 g in 100 g Docosanol (UNII: 9G1OE216XY) 1.48 g in 100 g HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) 0.4 g in 100 g ETHYLHEXYL PALMITATE (UNII: 2865993309) 0.5 g in 100 g PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) 3.5 g in 100 g POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 3 g in 100 g CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.127 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.58 g in 100 g CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.4825 g in 100 g HEXYLENE GLYCOL (UNII: KEH0A3F75J) 0.084 g in 100 g TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) 0.5 g in 100 g PANTHENOL (UNII: WV9CM0O67Z) 0.25 g in 100 g ETHYL LINOLEATE (UNII: MJ2YTT4J8M) 0.17 g in 100 g OLEYL ALCOHOL (UNII: 172F2WN8DV) 0.07 g in 100 g TOCOPHEROL (UNII: R0ZB2556P8) 0.005 g in 100 g SACCHAROMYCES LYSATE (UNII: R85W246Z1C) 0.59 g in 100 g TEA LEAF (UNII: GH42T47V24) 1.18 g in 100 g HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) 0.03 g in 100 g POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.14 g in 100 g SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.018 g in 100 g BIOTIN (UNII: 6SO6U10H04) 0.00004 g in 100 g HEXAPEPTIDE-10 (UNII: W9RS1K7T9I) 0.00025 g in 100 g BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.5 g in 100 g CARBOMER 934 (UNII: Z135WT9208) 0.025 g in 100 g POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.0125 g in 100 g PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) 0.00025 g in 100 g PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) 0.00013 g in 100 g VITIS VINIFERA SEED (UNII: C34U15ICXA) 0.01 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57975-161-02 1 in 1 CARTON 1 NDC:57975-161-01 63 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/15/2014 Labeler - BeautiControl (609044693) Establishment Name Address ID/FEI Business Operations BeautiControl 609044693 manufacture(57975-161)