SPORT SUNSCREEN SPF 30- avobenzone 3.0% homosalate 10.0% octisalate 5.0% octocrylene 10.0% lotion

Sport Sunscreen SPF 30 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn If used as directed with
other sun protection measures (see Directions), decreases
the risk of skin cancer and early skin aging caused by sun

WARNINGS

Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse eyes
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

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

Water, Ethylhexyl
Palmitate, Polyamide-8, Sorbitol, Tocopherol, Sodium
Ascorbyl Phosphate, Retinyl Palmitate, Diethylhexyl
Syringylidenemalonate, Caprylic/Capric Triglyceride,
Triethanolamine, Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Chlorphenesin, Oleth-3, Benzyl Alcohol,
Disodium EDTA, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SUNSCREEN SPF 30 
avobenzone 3.0% homosalate 10.0% octisalate 5.0% octocrylene 10.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-712
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	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
OLETH-3 (UNII: BQZ26235UC)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SORBITOL (UNII: 506T60A25R)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-712-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/12/2016

Labeler - TopCare (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-712) , label(36800-712)