Label: FRUIT OF THE EARTH SUN TOWN CITY BABY AND KIDS MINERAL SPF 50 SUNSCREEN- titanium dioxide, zinc oxide spray
- NDC Code(s): 62217-242-08
- 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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- 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.
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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
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Inactive ingredients
Water, Isohexadecane, Isododecane, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Shea Butter Ethyl Esters, Carthamus Tinctorius (Safflower) Seed Oil, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Butyloctyl Salicylate, Coco-Glucoside, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Sorbitan Olivate, Ethylhexylglycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Leaf Juice, Tocopherol, Glycerin, Sodium Gluconate, Citric Acid.
- Label
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SUN TOWN CITY BABY AND KIDS MINERAL SPF 50 SUNSCREEN
titanium dioxide, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 35 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 72.5 mg in 1 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETYL ALCOHOL (UNII: 936JST6JCN) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETEARYL OLIVATE (UNII: 58B69Q84JO) SODIUM GLUCONATE (UNII: R6Q3791S76) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISODODECANE (UNII: A8289P68Y2) SORBITAN OLIVATE (UNII: MDL271E3GR) COCO GLUCOSIDE (UNII: ICS790225B) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) SAFFLOWER OIL (UNII: 65UEH262IS) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) JOJOBA OIL (UNII: 724GKU717M) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-242-08 88 g in 1 CAN; Type 0: Not a Combination Product 02/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/07/2022 Labeler - Fruit Of The Earth, Inc. (079559467)
