Label: FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 62217-250-11, 62217-250-13
- Packager: Fruit Of The Earth, Inc.
- Category: HUMAN OTC DRUG LABEL
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 21, 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, Shea Butter Ethyl Esters, Isodecyl Neopentanoate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Cetearyl Olivate, PEG-100 Stearate, Diisopropyl Sebacate, Lauryl Lactate, Sorbitan Olivate, Silica, Glyceryl Caprylate, Stearyl/Octyldodecyl Citrate Crosspolymer, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, VP/Hexadecene Copolymer, Phenethyl Alcohol, Glycerin, Xanthan Gum, Ethylhexylglycerin, Tetrasodium EDTA, Sodium Hydroxide, Fragrance.
- Label
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 70 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) LAURYL LACTATE (UNII: G5SU0BFK7O) CETEARYL OLIVATE (UNII: 58B69Q84JO) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SORBITAN OLIVATE (UNII: MDL271E3GR) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) PEG-100 STEARATE (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-250-11 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/11/2021 2 NDC:62217-250-13 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/11/2021 Labeler - Fruit Of The Earth, Inc. (079559467)
