Label: FORCE SHIELD SUPERBEAM SUNSCREEN BROAD SPECTRUM SPF 30 APRICOT- zinc oxide cream

  • 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 December 2, 2022

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

  • Drug Facts

  • Active ingredient

    Zinc Oxide 17.53%

    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

    • irritation becomes severe.

    Keep out of reach of children.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.
    • 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 6 months: Ask a doctor
  • Inactive ingredients

    water (aqua), caprylic/capric triglyceride, propanediol, C13-15 alkane, C15-19 alkane, butyloctyl salicylate, bis-diglyceryl polyacyladipate-2, octyldodecanol, cetearyl alcohol, polyacrylate crosspolymer-6, hippophae rhamnoides oil, betaine, mica, musa sapientum (banana) leaf/trunk extract, silica, coco-glucoside, arachidyl alcohol, xanthan gum, polyhydroxystearic acid, polyglyceryl-3 polyricinoleate, isostearic acid, lecithin, polyglyceryl-3 lactate/laurate, polyglycerin-3, bisabolol, tocopherol, behenyl alcohol, caprylhydroxamic acid, sodium dilauramidoglutamide lysine, citric acid, arachidyl glucoside, ectoin, niacinamide, maltodextrin, sodium citrate, sodium phytate, terminalia ferdinandiana fruit extract, lactobacillus ferment, tin oxide, glucose, leuconostoc/radish root ferment filtrate, yellow iron oxide, red iron oxide, titanium dioxide

  • Question or comments?

    347-669-0686

  • Package Labeling:

    Label

    inner label

  • INGREDIENTS AND APPEARANCE
    FORCE SHIELD SUPERBEAM SUNSCREEN BROAD SPECTRUM SPF 30 APRICOT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73381-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION175.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    BETAINE (UNII: 3SCV180C9W)  
    MICA (UNII: V8A1AW0880)  
    BANANA (UNII: 4AJZ4765R9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ECTOINE (UNII: 7GXZ3858RY)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73381-004-001 in 1 CARTON12/01/202211/02/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/202211/02/2024
    Labeler - Hero Cosmetics Inc. (053668306)