Label: SPORT SUNSCREEN SPF 50 TOPCARE- homosalate 6.00% octinoxate 7.50% octisalate 5.00% octocrylene 10.00% zinc oxide 8.00% stick
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-865-01 - Packager: TopCo
- 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 May 9, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Homosalate 6.0%....................................................................Sunscreen
Octinoxate 7.5%......................................................................Sunscreen
Octisalate 5.0%.......................................................................Sunscreen
Octocrylene 10.0%..................................................................Sunscreen
Zinc Oxide 8.0%......................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• Apply liberally 15 minutes before sun exposure. • Reapply: • after 40
minutes of swimming or sweating • immediately after towel drying • at
least every 2 hours. • 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. • Children under 6 months of age: ask a doctor - OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Ceresin,
Chamomilla Recutita (Matricaria) Flower Extract, Copernicia Cerifera
(Carnauba) Wax, Dimethicone, Ethyl Macadamiate, Ethylhexyl Palmitate,
Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polyisobutene,
Malic Acid, Mentha Piperita (Peppermint) Oil, Octyldodecanol,
Polyethylene, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate,
Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane. - Questions? 1-888-423-0139
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPORT SUNSCREEN SPF 50 TOPCARE
homosalate 6.00% octinoxate 7.50% octisalate 5.00% octocrylene 10.00% zinc oxide 8.00% stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-865 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 6 g in 100 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 8 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Ceresin (UNII: Q1LS2UJO3A) CHAMOMILE (UNII: FGL3685T2X) CARNAUBA WAX (UNII: R12CBM0EIZ) Dimethicone (UNII: 92RU3N3Y1O) Ethyl Macadamiate (UNII: ANA2NCS6V1) Ethylhexyl Palmitate (UNII: 2865993309) SUNFLOWER OIL (UNII: 3W1JG795YI) Malic Acid (UNII: 817L1N4CKP) PEPPERMINT OIL (UNII: AV092KU4JH) Octyldodecanol (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Propylparaben (UNII: Z8IX2SC1OH) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Sorbitan Sesquioleate (UNII: 0W8RRI5W5A) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-865-01 14 g in 1 CONTAINER; Type 0: Not a Combination Product 01/25/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/25/2013 Labeler - TopCo (006935977) Registrant - Product Quest (927768135) Establishment Name Address ID/FEI Business Operations Product Quest 927768135 manufacture(36800-865)
