Label: FRUIT OF THE EARTH SUN TOWN CITY STICK MINERAL SPF 50- titanium dioxide, zinc oxide stick
- NDC Code(s): 62217-240-84
- 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 7, 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.
-
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
- Inactive ingredients
- Label
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY STICK MINERAL SPF 50
titanium dioxide, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-240 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 70 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 47 mg in 1 g Inactive Ingredients Ingredient Name Strength WHITE WAX (UNII: 7G1J5DA97F) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) PARAFFIN (UNII: I9O0E3H2ZE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CANDELILLA WAX (UNII: WL0328HX19) CERESIN (UNII: Q1LS2UJO3A) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) ISOSTEARIC ACID (UNII: X33R8U0062) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-240-84 1 in 1 BLISTER PACK 02/08/2022 1 18.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/08/2022 Labeler - Fruit of the Earth, Inc. (079559467)