Label: FRUIT OF THE EARTH SUN TOWN CITY DARK TANNING DRY OIL SPF 8 SUNSCREEN- homosalate, octisalate spray
- NDC Code(s): 62217-071-37
- 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 July 21, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Flammable:
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- Spray liberally and spread evenly by hand 15 minutes before sun exposure
- Hold can 4-6 inches away from the skin to apply
- Do not spray directly into face. Spray into hands then apply to face
- Do not apply in windy conditions
- Use in a well-ventilated area.
- 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, expecially from 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY DARK TANNING DRY OIL SPF 8 SUNSCREEN
homosalate, octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 70 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) MINERAL OIL (UNII: T5L8T28FGP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-071-37 156 g in 1 CAN; Type 0: Not a Combination Product 11/27/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/27/2019 Labeler - Fruit of the Earth, Inc. (079559467)
