SPORT SUNSCREEN SPF 70- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% spray 
TopCare

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
Avobenzone 3%..................................................................Sunscreen
Homosalate 15%.................................................................Sunscreen
Octisalate 5%......................................................................Sunscreen
Octocrylene 10%.................................................................Sunscreen
Oxybenzone 6%..................................................................Sunscreen

Uses • helps prevent sunburn • higher SPF gives more sunburn
protection • If used as directed with other sun protection measures
(see Directions), decreases the risk of skin cancer and early skin
aging caused by sun.

Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water
to remove. • Keep away from face to avoid breathing it • Do not
puncture or incinerate. Contents under pressure. Do not store at
temperatures above 120ºF.
Stop use and ask a doctor if rash occurs

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

Directions

• spray liberally and spread evenly by hand
15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face.
• do not apply in windy conditions
• use in a well-ventilated area
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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other information • protect this product from excessive heat and direct sun. • may stain fabrics.

Inactive Ingredients:
Acrylates/Octylacrylamide Copolymer
Alcohol Denat.
Caprylic/Capric Triglyceride
Diethylhexyl Syringylidenemalonate
Fragrance
Glycerin

image description

SPORT SUNSCREEN SPF 70 
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-728
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 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
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-728-05170 g in 1 CAN; Type 0: Not a Combination Product02/23/2016
2NDC:36800-728-06227 g in 1 CAN; Type 0: Not a Combination Product02/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/23/2016
Labeler - TopCare (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-728, 36800-728)

Revised: 7/2018
Document Id: 19c8ae34-66c2-4e4d-9148-7309758e6f93
Set id: 3ee8d815-b246-49ae-aed2-2b2692122069
Version: 1
Effective Time: 20180717
 
TopCare