Label: VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 59ML- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DOSAGE & ADMINISTRATION

    Dosage

  • INACTIVE INGREDIENT

    Inactive

  • INDICATIONS & USAGE

    Indications

  • PURPOSE

    OTC- Purpose

  • ACTIVE INGREDIENT

    OTC - Active

  • KEEP OUT OF REACH OF CHILDREN

    OTC - Children

  • USER SAFETY WARNINGS

    Safety Warnings

  • WARNINGS

    warnings

  • PRINCIPAL DISPLAY PANEL

    Principle Display Panel

  • PRINCIPAL DISPLAY PANEL

    59ml PDP

  • INGREDIENTS AND APPEARANCE
    VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 59ML 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.48 g  in 59 g
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    PHOSPHOLIPASE D1 (UNII: RO5LD48GLV)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-254-2082 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02007/28/2022
    Labeler - N.V Perricone LLC (054414243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc (DMI)076693183manufacture(45634-254)