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

Extreme Sport SPF 70 by

Drug Labeling and Warnings

Extreme Sport SPF 70 by is a Otc medication manufactured, distributed, or labeled by Top Care, Product Manufacturer Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                  Purpose

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

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

WarningsFor 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-727
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	15 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	4 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-727-04	141 g in 1 CAN; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2013

Labeler - Top Care (006935977)

Registrant - Product Manufacturer Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Manufacturer Mfg.		927768135	manufacture(36800-727) , label(36800-727)