Label: HIGH POTENCY CLASSICS FACE FINISHING AND FIRMING TINTED MOISTURIZER SPF 30- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 10, 2023

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  • DOSAGE & ADMINISTRATION

    dosage

  • ACTIVE INGREDIENT

    actives

  • INACTIVE INGREDIENT

    inactive ingredients

  • INDICATIONS & USAGE

    indications

  • KEEP OUT OF REACH OF CHILDREN

    children

  • PURPOSE

    purpose

  • WARNINGS

    warnings

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    HIGH POTENCY CLASSICS FACE FINISHING AND FIRMING TINTED MOISTURIZER SPF 30 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.478 g  in 59 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE (UNII: QHQ97HF0PY)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MANNITOL (UNII: 3OWL53L36A)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-137-2082 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02004/04/2022
    Labeler - N.V Perricone LLC (054414243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc (DMI)076693183manufacture(45634-137)