Label: HYPOALLERGENIC CBD SENSITIVE SKIN THERAPY ULTRA-LIGHTWEIGHT CALMING VEIL SPF 35- zinc oxide 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 September 7, 2023

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  • ACTIVE INGREDIENT

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

  • INDICATIONS & USAGE

    INDICATIONS & USAGE

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  • PURPOSE

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  • INGREDIENTS AND APPEARANCE
    HYPOALLERGENIC CBD SENSITIVE SKIN THERAPY ULTRA-LIGHTWEIGHT CALMING VEIL SPF 35 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-715
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.725 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    WATER (UNII: 059QF0KO0R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ROSEMARY (UNII: IJ67X351P9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    RICE BRAN (UNII: R60QEP13IC)  
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    LINGONBERRY (UNII: 0UNK9RZQ7X)  
    DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    C9-12 ALKANE (UNII: 7J5R5W72QM)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-715-5020000 mg in 1 TUBE; Type 0: Not a Combination Product09/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02009/05/2023
    Labeler - NV Perricone LLC (054414243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc (DMI)076693183manufacture(45634-715)