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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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.

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Drug Facts

Active ingredients                                                                   Purpose
Homosalate 6.0%....................................................................Sunscreen
Octinoxate 7.5%......................................................................Sunscreen
Octisalate 5.0%.......................................................................Sunscreen
Octocrylene 10.0%..................................................................Sunscreen
Zinc Oxide 8.0%......................................................................Sunscreen

Uses • helps prevent sunburn • higher SPF gives more sunburn
protection • retains SPF after 40 minutes of activity in the water
• provides high protection against sunburn

Warnings
For external use only
Do not use • on damaged or broken skin.
When using this product • keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if • rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 information • protect the product in this container from excessive heat and direct sun

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

image descriptionimage description

SPORT SUNSCREEN SPF 50  TOPCARE
homosalate 6.00% octinoxate 7.50% octisalate 5.00% octocrylene 10.00% zinc oxide 8.00% stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-865
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate6 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-865-0114 g in 1 CONTAINER; Type 0: Not a Combination Product01/25/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/25/2013
Labeler - TopCo (006935977)
Registrant - Product Quest (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest927768135manufacture(36800-865)

Revised: 5/2018
Document Id: e3335e97-2d21-48f9-b53d-3fa97975bd38
Set id: d1b8f502-a1d2-4b44-9538-6a818d66e5b8
Version: 1
Effective Time: 20180509
 
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