Label: EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 36 MEDIUM - DARK- titanium dioxide and zinc oxide lotion
- NDC Code(s): 71398-014-01
- Packager: SENTÉ, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 12, 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:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- 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 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), Dimethicone, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sodium Chloride, Heparan Sulfate, Glycerin, Fructose, Tocopheryl Acetate, Tocopherol, Withania Somnifera Root Extract, Iron Oxides (C.I. 77491, C.I. 77492, C.I. 77499), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Polyglyceryin-3 Crosspolymer, Stearic Acid, Alumina, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin.
- Other information
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- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 36 MEDIUM - DARK
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71398-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 47.43 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 87.048 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Dimethicone (UNII: 92RU3N3Y1O) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) Pentylene Glycol (UNII: 50C1307PZG) Hexyl Laurate (UNII: 4CG9F9W01Q) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Sodium Chloride (UNII: 451W47IQ8X) HEPARAN SULFATE (PORCINE 5500 MW) (UNII: 47959853R5) Glycerin (UNII: PDC6A3C0OX) Fructose (UNII: 6YSS42VSEV) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA) Stearic Acid (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71398-014-01 1 in 1 CARTON 06/10/2022 1 50 mL 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 06/10/2022 Labeler - SENTÉ, Inc. (079245446)
