Label: HEB TINTED 30 MINERAL SUNSCREEN FOR FACE- titanium dioxide, zinc oxide lotion
- NDC Code(s): 37808-145-09
- Packager: H.E.B.
- 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 March 14, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: Ask a doctor
- 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
- Other information
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Inactive ingredients
Water, Neopentyl Glycol Diheptanoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Sorbitan Sesquioleate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sorbitan Tristearate, Stearyl/Octyldodecyl Citrate Crosspolymer, VP/Hexadecene Copolymer, Simmondsia Chinensis(jojoba) Seed Oil, Phenoxyethanol, Magnesium Sulfate, Silica, Maranta Arundinacea(Arrowroot) Root Extract, Ethylhexylglycerin, Glyceryl Stearate, Tocopherol, Sodium Phytate, Stearyl Alcohol, Cetyl Alcohol, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Polysorbate 60, Sodium Hydroxide, Iron Oxides.
- Label
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INGREDIENTS AND APPEARANCE
HEB TINTED 30 MINERAL SUNSCREEN FOR FACE
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-145 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 35 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 33.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERYL 1-STEARATE (UNII: 258491E1RZ) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) POLYSORBATE 60 (UNII: CAL22UVI4M) JOJOBA OIL (UNII: 724GKU717M) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) HEXADECYL POVIDONE (UNII: AG75W62QYU) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHYTATE SODIUM (UNII: 88496G1ERL) SORBITAN TRISTEARATE (UNII: 6LUM696811) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A) SUNFLOWER OIL (UNII: 3W1JG795YI) SODIUM HYDROXIDE (UNII: 55X04QC32I) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-145-09 89 mL in 1 TUBE; Type 0: Not a Combination Product 01/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/28/2021 Labeler - H.E.B. (007924756)
