Label: INVISIBLE SHIELD FULL PHYSICAL TINTED SPF 52 BROAD SPECTRUM SUNSCREEN- titanium dioxide and zinc oxide lotion
- NDC Code(s): 71398-012-01
- Packager: SENTÉ, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 4, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
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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 of age: Ask a doctor
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Inactive ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Caprylyl Methicone, Acetamidoethoxyethanol, Steareth-2, Polyhydroxystearic Acid, Steareth-21, Glycerin, Biosaccharide Gum-4, Fructose, Withania Somnifera Root Extract, Yeast Extract, Hydrolyzed Candida Saitoana Extract, Cichorium Intybus (Chicory) Root Extract, Batyl Alcohol, Stearic Acid, Alumina, Triethoxycaprylylsilane, Xanthan Gum, Phytic Acid, Sodium Hydroxide, Propanediol, Caprylyl Glycol, Caprylhydroxamic Acid, 1,2-Hexanediol, Disodium EDTA, Iron Oxides (CI 77491, CI 77492, CI 77499)
- Other information
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- PRINCIPAL DISPLAY PANEL - 52 g Tube Carton
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INGREDIENTS AND APPEARANCE
INVISIBLE SHIELD FULL PHYSICAL TINTED SPF 52 BROAD SPECTRUM SUNSCREEN
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71398-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 57.5 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 111.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Caprylyl Trisiloxane (UNII: Q95M2P1KJL) Steareth-2 (UNII: V56DFE46J5) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Steareth-21 (UNII: 53J3F32P58) Glycerin (UNII: PDC6A3C0OX) Biosaccharide Gum-4 (UNII: 9XRL057X90) Fructose (UNII: 6YSS42VSEV) Withania Somnifera Root (UNII: V038D626IF) Yeast, Unspecified (UNII: 3NY3SM6B8U) CICHORIUM INTYBUS (CHICORY) ROOT OLIGOSACCHARIDES (UNII: 38AFY41EAR) Batilol (UNII: 39YR661C4U) Stearic Acid (UNII: 4ELV7Z65AP) Aluminum Oxide (UNII: LMI26O6933) Triethoxycaprylylsilane (UNII: LDC331P08E) Xanthan Gum (UNII: TTV12P4NEE) Fytic Acid (UNII: 7IGF0S7R8I) Propanediol (UNII: 5965N8W85T) Caprylyl Glycol (UNII: 00YIU5438U) Caprylhydroxamic Acid (UNII: UPY805K99W) 1,2-Hexanediol (UNII: TR046Y3K1G) Edetate Disodium (UNII: 7FLD91C86K) Ferrosoferric Oxide (UNII: XM0M87F357) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Sodium Hydroxide (UNII: 55X04QC32I) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71398-012-01 1 in 1 CARTON 05/15/2019 1 52 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 05/15/2019 Labeler - SENTÉ, Inc. (079245446)
