SPORT SUNSCREEN SPF 50 TOPCARE- avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 5.00% spray

Sport Sunscreen SPF 50 by

Drug Labeling and Warnings

Sport Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Topco, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                 Purpose

Avobenzone - 3.00%
Homosalate - 10.00%
Octisalate - 5.00%
Octocrylene - 5.00%                                  Sunscreen

PURPOSE

INDICATIONS & USAGE

- 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.

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SUNSCREEN SPF 50  TOPCARE
avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 5.00% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-868
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	10 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-868-05	170 g in 1 CAN; Type 0: Not a Combination Product	02/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/29/2016

Labeler - Topco (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-868) , label(36800-868)