Label: OARS AND ALPS SPF 50 100% MINERAL ANTIOXIDANT SUNSCREEN- titanium dioxide, zinc oxide spray

  • 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 January 31, 2023

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  • ACTIVE INGREDIENT

    Titanium Dioxide - 3.4%

    Zinc Oxide - 15.7%

  • 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.
    • 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 contact a Poison Control Center right away.

  • Directions

    • Apply generously and evenly 15 minutes before sun exposure
    • Hold container 4-6 inches from the skin to apply
    • Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale.
    • Do not apply in windy conditions.
    • Use in well ventilated area.
    • Reapply: After 80 minutes of swimming or sweating, immedately after towl 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 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 sunglasses.​
    • Children under six months: Ask a doctor.
  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sclerocarya Birrea Seed Oil, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water

  • OTHER SAFETY INFORMATION

    • Protect the product in this container from excessive heat and direct sun
    • Avoid spraying on facbrics - may cause discoloration
  • QUESTIONS

    Contact Hi@oarsandalps.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    OARS AND ALPS SPF 50 100% MINERAL ANTIOXIDANT SUNSCREEN 
    titanium dioxide, zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83046-369
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.7 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    WATER (UNII: 059QF0KO0R)  
    C18-C21 ALKANE (UNII: 33822S0M40)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83046-369-13177 mL in 1 CAN; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02012/01/2022
    Labeler - Oars and Alps LLC (040241941)
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