SPORT SUNSCREEN SPF 30 TOPCARE- avobenzone 2.00% homosalate 7.00% octocrylene 5.00% spray 
TopCo

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 - 2.00%
Homosalate - 7.00%
Octocrylene - 5.00%                                  Sunscreen

- helps prevent sunburn
- if used as directed with other sun protection messures (see Directions) decreases the risk of skin cancer and early skin aging caused by sun.

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 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
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

Inactive ingredients

Acrylates/Dimethicone Copolymer
Acrylates/Octylacrylamide Copolymer
Alcohol Denat.
Aloe Barbadensis Leaf Extract
Cyclopentasiloxane
Dimethicone
Fragrance
Polyester-8
PPG-5-Ceteth-20
Tocopheryl Acetate
Trisiloxane

image description

SPORT SUNSCREEN SPF 30  TOPCARE
avobenzone 2.00% homosalate 7.00% octocrylene 5.00% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-869
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone2 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate7 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE (UNII: V5VD430YW9)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Trisiloxane (UNII: 9G1ZW13R0G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-869-05170 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 - TopCo (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-869) , label(36800-869)

Revised: 5/2018
Document Id: eb505720-5e09-432b-85e9-1cc447ef7103
Set id: f23828f7-af34-4dd1-817d-e4da66ca4dcb
Version: 1
Effective Time: 20180525
 
TopCo