SPORT SUNSCREEN SPF 30- avobenzone 3% homosalate 10% octisalate 5% octocrylene 2% oxybenzone 4% spray

Sport Sunscreen SPF 30 by

Drug Labeling and Warnings

Sport Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Quality Choice, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                         Purpose
Avobenzone 3.0%.........................................................................Sunscreen
Homosalate 10.0%........................................................................Sunscreen
Octisalate 5.0%............................................................................Sunscreen
Octocrylene 2.0%..........................................................................Sunscreen
Oxybenzone 4.0%.........................................................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn higher SPF gives more sunburn protection
retains SPF after 80 minutes of activity in the water or sweating provides high
protection against sunburn

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive ingredients

Acrylates/Octylacrylamide Copolymer,
Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl
Syringylidenemalonate, Fragrance, Glycerin, Retinyl Palmitate,
Stearoxytrimethylsilane, Tocopherol.

QUESTIONS

Questions? 248-449-9300

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SUNSCREEN SPF 30 
avobenzone 3% homosalate 10% octisalate 5% octocrylene 2% oxybenzone 4% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-783
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 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	2 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)
Glycerin (UNII: PDC6A3C0OX)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Stearoxytrimethylsilane (UNII: 9862TW94B2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-783-05	177 mL in 1 CAN; Type 0: Not a Combination Product	03/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/20/2012

Labeler - Quality Choice (011920774)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(63868-783) , label(63868-783)