Label: SUN SHIELD CLEAR SPF 30 BROAD SPECTRUM MINERAL CONTINUOUS- zinc oxide spf 30 mineral spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 14, 2021

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  • Active Ingredient

    Zinc Oxide..............12%

    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 puncture or incinerate can
    • Keep away from fire and flames
    • For external use only.
    • Do not spray directly on face
    • Do not use on damaged or broken skin.
    • When using this rpoduct keep out of eyes. Rinse with water ro remove.
    • Stop use and ask a doctor if rash and irritation develops and lasts.

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

  • Directions

    • Shake well. Spray liberally and spread evenly by hand 15 minutes before sun exposure.
    • Hold container 4 to 6 inches from skin to apply.
    • Do not spray directly on face. Spray on hands and apply to face.
    • Avoid inhaling or exposing others to spray.
    • Reapply:
      • After 80 minutes of swimming or sweating.
      • Immediately after towel drying
      • 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 of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 a.m. - 2 p.m.
      • Weat long-sleeve shirts, pants, hats and sunglasses.
  • Inactive Ingredients

    Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Triethyl Citrate, Vanila Planifolia Fruit Extract, Water

  • Other Information

    • Protect this product from excessive heat and direct sun.
    • Store at temperatures below 90oF
    • May stain some fabrics.
  • 6 oz label

    6 oz label

  • INGREDIENTS AND APPEARANCE
    SUN SHIELD CLEAR  SPF 30 BROAD SPECTRUM MINERAL CONTINUOUS
    zinc oxide spf 30 mineral spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    VANILLA PLANIFOLIA FLOWER (UNII: 33NF0M2062)  
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76150-142-13177 mL in 1 CAN; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2015
    Labeler - Bell International Laboratories, Inc. (967781555)
    Registrant - Bell International Laboratories, Inc. (967781555)