SPORT SUNSCREEN SPF 30 QUALITY CHOICE- avobenzone 2.0% homosalate 10.0% octisalate 5.0% octocrylene 4.0% oxybenzone 5.0% lotion

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 2%...........................................Sunscreen
Homosalate 10%.........................................Sunscreen
Octisalate 5%..............................................Sunscreen
Octocrylene 4%..........................................Sunscreen
Oxybenzone 5%..........................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

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

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

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Benzyl Alcohol, Chlorphenesin, Disodium EDTA, Fragrance,
Neopentyl Glycol Diheptanoate, Oleth-3, Polyamide-8, Propylene Glycol,
Tocopherol, Triethanolamine, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SUNSCREEN SPF 30  QUALITY CHOICE
avobenzone 2.0% homosalate 10.0% octisalate 5.0% octocrylene 4.0% oxybenzone 5.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-778
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 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	4 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Benzyl Alcohol (UNII: LKG8494WBH)
Chlorphenesin (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)
Oleth-3 (UNII: BQZ26235UC)
Propylene Glycol (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-778-06	473 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/11/2014

Labeler - Quality Choice (011920774)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(63868-778) , label(63868-778)