Label: FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 62217-248-13, 62217-248-49
- Packager: Fruit Of The Earth, 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 February 10, 2023
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- 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, Caprylic/Capric Triglyceride, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Glyceryl Stearate, Glycerin, Olive Oil Polyglyceryl-6 Esters, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Phenoxyethanol, Polyglyceryl-6 Pentaoleate, Stearyl/Octyldodecyl Citrate Crosspolymer, VP/Hexadecene Copolymer, Magnesium Sulfate, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Tocopherol, Sodium Hydroxide, Fragrance.
- Label
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-248 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 150 mg in 1 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) JOJOBA OIL (UNII: 724GKU717M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) OAT (UNII: Z6J799EAJK) MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-248-13 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2021 2 NDC:62217-248-49 42 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/27/2021 Labeler - Fruit Of The Earth, Inc. (079559467)
