Label: MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide, titanium dioxide spray

  • NDC Code(s): 64768-2927-1
  • Packager: Expanscience Laboratories d/b/a Mustela
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • 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

    • Do not store at temperature above 120F.
    • Contents under pressure. Do not puncture or incinerate can.
    • Avoid using on children under 3
    • For external use only. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

    Do not use

    on damaged or broken skin

    When using this product

    keep away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor

    if rash occurs

    Keep out of reach of children.

    If a product is swallowed get medical help or contact a Poison Control center right away.

  • 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 - 2p.m
    • Wear long-sleeved shirt, pants, hat, and sunglasses
    • Children under 6 months: ask a doctor.
  • Other information

    • Protect this product from excessive heat and direct sun.
    • You may report a serious adverse event to the phone number or address provided below.
    • May stain some fabrics.
  • Inactive ingredients

    Water, 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, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol*, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Spiraea Ulmaria Flower Extract*, Nasturtium Officinale Flower/Leaf Extract*, *Certified Organic Ingredients

  • Questions or comments?

    Call toll free 1-800-422-2987
    Monday-Friday 9:00am-5:00pm EST

  • Company Information

    MADE IN THE USA from globally sourced materials for
    Expanscience Laboratories Inc.,
    Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022
    www.MustelaUSA.com

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
    zinc oxide, titanium dioxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64768-2927
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE147 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CHAMOMILE (UNII: FGL3685T2X)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64768-2927-1170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2021
    Labeler - Expanscience Laboratories d/b/a Mustela (181191057)
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