Label: TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
- NDC Code(s): 36800-312-37
- Packager: TOPCO ASSOCIATES LLC
- 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 January 25, 2023
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- 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
• apply liberally 15 minutes before sun exposure
• hold can 4-6 inches away from body, spray evenly to ensure complete coverage
• do not spray into face. Spray into hand and apply to face.
• use in well ventilated, but not windy 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 - Inactive ingredients
- Other Information
- Label
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INGREDIENTS AND APPEARANCE
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-312-37 156 g in 1 CAN; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2018 Labeler - TOPCO ASSOCIATES LLC (006935977)