Label: POLLUTION SHIELD SPF 46 BROAD SPECTRUM SUNSCREEN- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71398-001-01, 71398-001-02, 71398-001-04 - Packager: SENTÉ, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 12, 2017
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- Download DRUG LABEL INFO: PDF XML
- 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 10a.m.-2p.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), Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Glycerin, Steareth-2, Cetearyl Alcohol, Polymethylsilsesquioxane, Steareth-21, Silica, Polyhydroxystearic Acid, Hydrolyzed Candida Saitoana Extract, Glycine Max (Soybean) Seed Extract, Yeast Extract, Biosaccharide Gum-4, Dimethicone, Dipotassium Glycyrrhizate, Propanediol, Stearic Acid, Triethoxycaprylylsilane, Sodium Stearoyl Glutamate, 1,2-Hexanediol, Sodium C14-16 Olefin Sulfonate, Caprylhydroxamic Acid, Alumina, Caprylyl Glycol, Xanthan Gum, Disodium EDTA. Iron Oxides (Cl 77491, Cl 77492, Cl 77499).
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 52 g Tube Carton
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INGREDIENTS AND APPEARANCE
POLLUTION SHIELD SPF 46 BROAD SPECTRUM SUNSCREEN
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71398-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 53 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 145 mg in 1 g Inactive Ingredients Ingredient Name Strength Dicaprylyl Carbonate (UNII: 609A3V1SUA) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Glycerin (UNII: PDC6A3C0OX) Steareth-2 (UNII: V56DFE46J5) Cetostearyl Alcohol (UNII: 2DMT128M1S) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) Steareth-21 (UNII: 53J3F32P58) Silicon Dioxide (UNII: ETJ7Z6XBU4) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Soybean (UNII: L7HT8F1ZOD) Yeast, Unspecified (UNII: 3NY3SM6B8U) Biosaccharide Gum-4 (UNII: 9XRL057X90) Dimethicone (UNII: 92RU3N3Y1O) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Propanediol (UNII: 5965N8W85T) Stearic Acid (UNII: 4ELV7Z65AP) Triethoxycaprylylsilane (UNII: LDC331P08E) Sodium Stearoyl Glutamate (UNII: 65A9F4P024) 1,2-Hexanediol (UNII: TR046Y3K1G) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Caprylhydroxamic Acid (UNII: UPY805K99W) Aluminum Oxide (UNII: LMI26O6933) Caprylyl Glycol (UNII: 00YIU5438U) Xanthan Gum (UNII: TTV12P4NEE) Edetate Disodium (UNII: 7FLD91C86K) Ferrosoferric Oxide (UNII: XM0M87F357) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Product Characteristics Color BROWN (Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71398-001-01 1 in 1 CARTON 06/15/2017 1 52 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71398-001-04 1 in 1 BLISTER PACK 06/15/2017 2 2 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:71398-001-02 1 in 1 CARTON 06/15/2017 3 11.3 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 FINAL part352 06/15/2017 Labeler - SENTÉ, Inc. (079245446)
