Label: INVISIBLE HERO SPF30- sunscreen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 82071-042-02 - Packager: Clark's Botanicals, LLC
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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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
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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
- Questions or Comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INVISIBLE HERO SPF30
sunscreen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82071-042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 15 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82071-042-02 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/02/2021 Labeler - Clark's Botanicals, LLC (791538528) Registrant - Products by O2, Inc. (136932444) Establishment Name Address ID/FEI Business Operations Products by O2, Inc. 136932444 manufacture(82071-042)