Label: TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 36800-239-37, 36800-239-62, 36800-239-63
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 4, 2021
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 a 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 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, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses - Other information
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Inactive ingredients
alcohol denat., isododecane, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, ascorbyl palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract, fragrance
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-239 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MINERAL OIL (UNII: T5L8T28FGP) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) ASCORBYL PALMITATE (UNII: QN83US2B0N) PANTHENOL (UNII: WV9CM0O67Z) ISODODECANE (UNII: A8289P68Y2) METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-239-37 156 g in 1 CAN; Type 0: Not a Combination Product 01/04/2017 2 NDC:36800-239-63 2 in 1 PACKAGE 01/04/2017 2 NDC:36800-239-37 156 g in 1 CAN; Type 0: Not a Combination Product 3 NDC:36800-239-62 3 in 1 PACKAGE 01/04/2017 3 NDC:36800-239-37 156 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/04/2017 Labeler - TOPCO ASSOCIATES LLC (006935977)
