SPORT SPF 15- avobenzone 2% homosalate 10% octisalate 5% oxybenzone 3% spray

Sport SPF 15 by

Drug Labeling and Warnings

Sport SPF 15 by is a Otc medication manufactured, distributed, or labeled by TopCare, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                          Purpose
Avobenzone 2%............................................................................Sunscreen
Homosalate 10%..........................................................................Sunscreen
Octisalate 5%...............................................................................Sunscreen
Oxybenzone 3%............................................................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn higher SPF gives more sunburn protection

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

OTHER SAFETY INFORMATION

Other information
protect this product from excessive heat and direct sun. may stain fabrics

INACTIVE INGREDIENT

Inactive ingredients
Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Fragrance, Glycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SPF 15 
avobenzone 2% homosalate 10% octisalate 5% oxybenzone 3% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2 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
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-725-05	170 g in 1 CAN; Type 0: Not a Combination Product	02/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/10/2017

Labeler - TopCare (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-725) , label(36800-725)