Label: SPF 50 SHEER MINERAL SENSITIVE SUNSCREEN- mineral sunscreen aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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

  • Active ingredients

    Titanium Dioxide 4.3%

    Zinc Oxide 14.7%

  • Purpose

    Sunscreen

  • Uses

    • 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

    For external use only.

    Do not use

    on damaged or broken skin

    When using this product

    • keep out of eyes. Rinse with water to remove.
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    Stop use and ask doctor if

    • rash occurs
    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120° F.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • Shake well before use • Hold container 4 to 6 inches from the skin to apply • Apply liberally 15 minutes before sun exposure • Do not spray directly into face • Do not spray in windy condition • Use in well-ventilated area • Reapply: After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours. 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 of 15 or higher and other protection measures including: • Limit time in the sun, especially from 10 A.M. - 2 P.M. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor

  • Other Information

    • Protect this product from excessive heat and direct sun. May stain some fabrics and surfaces.

  • Inactive ingredients

    Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Glycerin, Bisabolol*, Tocopherol (Vitamin E), Bentonite, Caprylyl Glycol, Coco-Glucoside, Citric Acid, Sodium Gluconate, Cellulose Gum, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Caprylhydroxamic Acid, Polyhydroxystearic Acid, Alumina, Silica.

    *Certified Organic Ingredients

  • Questions and comments?

    Call 1-800-422-2987 Mon - Fri 9:00AM - 5:00PM EST

  • SPF 50 Sheer Mineral Sensitive Spray Sunscreen

    1

  • INGREDIENTS AND APPEARANCE
    SPF 50 SHEER MINERAL SENSITIVE SUNSCREEN 
    mineral sunscreen aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8797
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.65 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8797-6177 mL in 1 CAN; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/202006/30/2024
    Labeler - Babo Botanicals, Inc. (058258734)