Label: WILD MINT CLEAR SPF 45- zinc oxide lotion

  • 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 April 12, 2021

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  • ACTIVE INGREDIENT

    Titanium Dioxide 7.0%

    Zinc Oxide 9.0%

  • DOSAGE & ADMINISTRATION

    Directions for use

  • PURPOSE

    Sunscreen

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INACTIVE INGREDIENT

    Water (Aqua), Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Polyglyceryl-2 Sesquioleate, Glycerin, Polyglyceryl-3 Ricinoleate, Aloe Barbadensis Leaf Juice (1), Crambe Abyssinica Seed Oil, Polyhydroxystearic Acid, Alumina, Stearic Acid, Mentha Piperita (Peppermint) Oil, Salvia Officinalis (Sage) Oil, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1),Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Tocopheryl Acetate, Alcohol (1), Butyrospermum Parkii (Shea) Butter, Coco-Caprylate/Caprate, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Benzyl Alcohol, Phenoxyethanol, Limonene, Linalool.

    (1) Certified Organic Ingredient

  • INDICATIONS & USAGE

    Uses

  • PRINCIPAL DISPLAY PANEL

    AL00970 Label

  • INGREDIENTS AND APPEARANCE
    WILD MINT CLEAR SPF 45 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1970
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-2 SESQUIOLEATE (UNII: RHP7Q83BVB)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALCOHOL (UNII: 3K9958V90M)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1970-185 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2019
    Labeler - The Hain Celestial Group, Inc (117115556)
    Registrant - The Hain Celestial Group, Inc (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc081512382manufacture(61995-1970)