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
- 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 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)
