REGENERATION WRINKLE CONTROL CREAM SPF 15- avobenzone, homosalate, octocrylene cream 
BeautiControl

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.

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REGENERATION WRINKLE CONTROL CREAM  SPF 15
avobenzone, homosalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57975-161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57975-161-021 in 1 CARTON
1NDC:57975-161-0163 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/15/2014
Labeler - BeautiControl (609044693)
Establishment
NameAddressID/FEIBusiness Operations
BeautiControl609044693manufacture(57975-161)

Revised: 2/2016
Document Id: d78c79d0-20b6-4e46-b3f9-7facbd3a2c9f
Set id: ccaf8e81-8028-49c7-a1f2-5a8c6f57d09c
Version: 1
Effective Time: 20160205
 
BeautiControl