Label: FRUIT OF THE EARTH SUN TOWN CITY DARK TANNING SPF 8 SUNSCREEN- avobenzone, octisalate, octocrylene lotion
- NDC Code(s): 62217-072-11
- 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 21, 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, octyldodecyl neopentanoate, glycerin, butyloctyl salicylate, cetearyl alcohol, polysorbate 60, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, triethanolamine, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY DARK TANNING SPF 8 SUNSCREEN
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 15 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TROLAMINE (UNII: 9O3K93S3TK) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) DIPROPYLENE GLYCOL (UNII: E107L85C40) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) PEG-100 STEARATE (UNII: YD01N1999R) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-072-11 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/09/2019 Labeler - Fruit of the Earth, Inc. (079559467)
