Label: INVISIBLE HERO SPF30- sunscreen liquid

  • 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 August 1, 2021

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  • Active Ingredient

    Zinc Oxide, 15%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally at least 15 minutes before sun exposure
    • Apply as the last step in your skincare routine
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply 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 higer and other sun protection measures includuing:
    - Limit time in the sun, especailly from 10 AM to 2 PM
    - Wear long-sleeve shirts, pants, hats, and sunglasses


    • Children under 6 months: Ask a doctor
  • Inactive Ingredients

    Water (Aqua), Coco-Caprylate, Glycerin, Sorbitan Olivate, C15-19 Alkane, C12-15 Alkyl Benzoate, Cetearyl Olivate, Coco-Glucoside, Xylitylglucoside, Coconut Alcohol, Zinc Sulfate, Anhydroxylitol, Jasminum Officinale (Jasmine) Extract, Arnica Montana (Arnica) Flower Extract, Hypnea Musciformis (Algae) Extract, Niacinamide, Vitis Vinifera (Grape) Leaf Extract, Inula Helenium (Elecampane) Extract, Sodium hyaluronate, Radish Root Ferment Filtrate, Polyhydroxystearic Acid, Trimethylolpropane Triethylhexanoate, Cetyl Ethylhexanoate, Sodium Phytate, Xanthan Gum, Caprylhydroxamic Acid, Glyceryl Caprylate, Benzyl Alcohol, Benzoic Acid, Natural Fragrance, Geraniol, Linalool, d -Limonene, Eugenol

  • Other Warnings

    Protect this product from excessive heat and direct sun

  • Questions or Comments

    Call 1-917-970-1250 (9 AM to 5 PM ET)

  • SPL UNCLASSIFIED SECTION

    Distributed by Clark's Botanicals, LLC
    Bronxville, NY
    clarksbotanicals.com

  • PRINCIPAL DISPLAY PANEL

    Clark's Botanicals
    Invisible Hero SPF 30
    Anti-Aging Sunscreen with Hyaluronic Acid
    Broad Spectrum SPF 30 PA+++

    Poids Net Wt. 1.7 fl. oz.| 50 mL

    CBHero

  • INGREDIENTS AND APPEARANCE
    INVISIBLE HERO SPF30 
    sunscreen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82071-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    JASMINUM OFFICINALE FRUIT (UNII: RFR735L94A)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    VITIS VINIFERA LEAF (UNII: R1H893D80E)  
    INULA HELENIUM ROOT (UNII: E55SMD6DA8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    RADISH (UNII: EM5RP35463)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    EUGENOL (UNII: 3T8H1794QW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82071-042-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/02/2021
    Labeler - Clark's Botanicals, LLC (791538528)
    Registrant - Products by O2, Inc. (136932444)
    Establishment
    NameAddressID/FEIBusiness Operations
    Products by O2, Inc.136932444manufacture(82071-042)
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