SPORT SPF 30- avobenzone 1.8% homosalate 7.0% octocrylene 5.0% lotion

Sport SPF 30 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                               Purpose
Avobenzone 1.8%.............................Sunscreen
Homosalate 7.0%..............................Sunscreen
Octocrylene 5.0%.............................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

Water,
Butyloctyl Salicylate, Sorbitol, Aluminum
Starch Octenylsuccinate, VP/Eicosene
Copolymer, Stearic Acid, Benzyl Alcohol,
Carbomer, Dimethicone, Disodium EDTA,
Methylparaben, Polyglyceryl-3 Distearate,
Propylparaben, Sorbitan Isostearate,
Tocopherol, Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SPF 30 
avobenzone 1.8% homosalate 7.0% octocrylene 5.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-713
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	1.8 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	7 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Benzyl Alcohol (UNII: LKG8494WBH)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Dimethicone (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Methylparaben (UNII: A2I8C7HI9T)
Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)
Propylparaben (UNII: Z8IX2SC1OH)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Sorbitol (UNII: 506T60A25R)
Stearic Acid (UNII: 4ELV7Z65AP)
Tocopherol (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-713-06	237 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/22/2016

Labeler - Top Care (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-713) , label(36800-713)