Label: HYDRATING MINERAL SUNSCREEN BS SPF30- zinc oxide cream

  • NDC Code(s): 62742-4260-1, 62742-4260-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 21%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Use • helps prevent sunburn.• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warnings For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • apply liberally 15 minutes before sun exposure •reapply at least every 2 hours • children under 6 months: Ask a doctor • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sun-glasses.

  • OTHER SAFETY INFORMATION

    Other information protect this product from excessive heat and direct sun.

    CAUTION:

    IF YOU HAVE A KNOWN ALLERGY OR EXPERIENCE SENSITIVITY TO ANY OF THE LIST INGREDIENTS, DISCONTINUE USE. FOR EXTERNAL USE ONLY, DO NOT APPLY TO OPEN WOUNDS.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Glyceryl Caprylate, Coco-Glucoside, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Honey, Avena sativa (Oat) Kernel Flour, Sodium Phytate, Caprylyl/Capryl Glucoside, Xanthan Gum, Dipotassium Glycyrrhizate, Sclerotium Gum, Cetearyl Glucoside, Butyrospermum Parkii (Shea) Butter, Tocopherol, Coco-Caprylate/Caprate, Caprylhydroxamic acid, Sucrose, Spirulina Maxima Extract, Phaeodactylum Tricornutum Extract, Oryza Sativa Starch, Bisabolol,Lecithin, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Beta-Sitosterol, Squalene, Glucose, C8 Alcohol, C10 Alcohol

  • PRINCIPAL DISPLAY PANEL

    Hydrating Mineral Sunscreen BS SPF 30

  • INGREDIENTS AND APPEARANCE
    HYDRATING MINERAL SUNSCREEN BS SPF30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SQUALENE (UNII: 7QWM220FJH)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)  
    DECYL ALCOHOL (UNII: 89V4LX791F)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    OATMEAL (UNII: 8PI54V663Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUCROSE (UNII: C151H8M554)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4260-21 in 1 CARTON04/15/2024
    1NDC:62742-4260-148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/15/2024
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4260)