Label: HERO FORCE SHIELD SPF 30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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

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  • 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

    • rash occurs.

    Keep out of reach of children.

    • If product is swallowed, get medical help or contact a Poison Control Center right away.
  • 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.
  • Other information

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
    • Protect this product from excessive heat or direct sun.
  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Propanediol, C15-19 Alkane, Bis-Diglyceryl Polyacyladipate-2, Butyloctyl Salicylate, Ectoin, Alteromonas (Abyssine) Ferment Extract, Harungana Madagascariensis (Madagascar) Extract, Ipomoea Batatas (Purple Sweet Potato) Root Extract, Rubus Idaeus (Raspberry) Seed Oil, Camellia Sinensis (Green Tea) Leaf Extract, Corallina Officinalis (Red Algae) Extract, Curcuma Longa (Turmeric) Leaf Extract, Melia Azadirachta (Neem) Flower Extract, Melia Azadirachta (Neem) Leaf Extract, Moringa Oleifera Seed Oil, Ocimum Sanctum (Holy Basil) Leaf Extract, Oryza Sativa (Rice) Hull Extract, Solanum Melongena (Eggplant) Fruit Extract, Coccinia Indica (Ivy Gourd) Fruit Extract, Tocopherol (Vitamin E), Bisabolol, Amber Powder, Coco-Glucoside, Glucose, Glycerin, Xanthan Gum, 1,2-Hexanediol, Caprylhydroxamic Acid, Arachidyl Alcohol, Arachidyl Glucoside, Hydroxyacetophenone, Polyacrylate Crosspolymer-6, Behenyl Alcohol, Cetearyl Alcohol, Isostearic Acid, Lecithin, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Silica, t-Butyl Alcohol, Sodium Benzoate, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sodium Phytate, Citric Acid, Inositol, Lactobacillus Ferment Lysate, Saccharomyces Lysate, Butylene Glycol, Caprylyl Glycol.

  • Questions or comments?

    347-669-0686

  • Package Labeling:

    LabelTube

  • INGREDIENTS AND APPEARANCE
    HERO FORCE SHIELD SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73381-506
    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)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ECTOINE (UNII: 7GXZ3858RY)  
    ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)  
    SWEET POTATO (UNII: M9WGG9Z9GK)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    RICE BRAN (UNII: R60QEP13IC)  
    EGGPLANT (UNII: W5K7RAS4VK)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    AMBER (UNII: 70J9Z0J26P)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INOSITOL (UNII: 4L6452S749)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73381-506-1010 mL in 1 TUBE; Type 0: Not a Combination Product06/01/202110/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/202110/24/2024
    Labeler - Hero Cosmetics, Inc. (053668306)
    Establishment
    NameAddressID/FEIBusiness Operations
    Innovation Labs, Inc.117109069manufacture(73381-506)