EXTREME SPORT SPF 70- avobenzone - 3.00% homosalate - 15.00% octisalate - 5.00% octocrylene - 4.00% oxybenzone - 6.00% spray 
Top Care

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 Facts

Active ingredients                  Purpose

Avobenzone - 3.00%               Sunscreen
Homosalate - 15.00%              Sunscreen
Octisalate - 5.00%                   Sunscreen
Octocrylene - 4.00%                Sunscreen
Oxybenzone - 6.00%               Sunscreen

Uses • helps prevent sunburn

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 with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperature 120F

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

• apply liberally 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., Artemia Extract, Ascorbyl Palmitate, Butyloctyl Salicylate, Cyclopentasiloxane, Fragrance, Glycerin, Polyester-8, Retinyl Palmitate, Tocopheryl Acetate

image description

EXTREME SPORT SPF 70 
avobenzone - 3.00% homosalate - 15.00% octisalate - 5.00% octocrylene - 4.00% oxybenzone - 6.00% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-727
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) Octocrylene4 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BRINE SHRIMP (UNII: 3ID50N77DH)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Glycerin (UNII: PDC6A3C0OX)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-727-04141 g in 1 CAN; Type 0: Not a Combination Product07/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2013
Labeler - Top Care (006935977)
Registrant - Product Manufacturer Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Manufacturer Mfg.927768135manufacture(36800-727) , label(36800-727)

Revised: 7/2018
Document Id: 8f06d56e-f609-4904-833f-ae8ed74354cc
Set id: deffcf4e-30ab-4bfd-bf90-403ffdb04971
Version: 1
Effective Time: 20180717
 
Top Care