Label: FRUIT OF THE EARTH SUN TOWN CITY SPF 50 ZINC SUNSCREEN- octocrylene, zinc oxide lotion
- NDC Code(s): 62217-075-42, 62217-075-43
- Packager: Fruit of the Earth, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 22, 2021
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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, ethylhexyl stearate, diisopropyl adipate, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, hydrogenated castor oil, polyglyceryl-4 isostearate, hexyl laurate, beeswax, isohexadecane, phenoxyethanol, silica, ethylhexylglycerin, triethoxycaprylylsilane, dimethicone, sodium chloride, disodium EDTA, aloe barbadensis leaf powder, sodium ascorbyl phosphate, tocopherol, fragrance.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY SPF 50 ZINC SUNSCREEN
octocrylene, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 40 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) WHITE WAX (UNII: 7G1J5DA97F) DIMETHICONE (UNII: 92RU3N3Y1O) ISOHEXADECANE (UNII: 918X1OUF1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-075-43 1 in 1 CARTON 01/20/2020 1 NDC:62217-075-42 29.6 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/20/2020 Labeler - Fruit of the Earth, Inc. (079559467)
