Label: FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 62217-251-37, 62217-251-74
- 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 21, 2023
If you are a consumer or patient 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 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 skin top apply
• do not spray into face. Spray into hand and apply to face.
• use in a well ventilated areas
reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours• children under 6 months: 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
- Inactive ingredients
- Label
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 70 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-251 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 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-251-74 76.5 g in 1 CAN; Type 0: Not a Combination Product 10/13/2021 2 NDC:62217-251-37 156 g in 1 CAN; Type 0: Not a Combination Product 10/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/13/2021 Labeler - Fruit Of The Earth, Inc. (079559467)
