SPORT SUNSCREEN SPF 50 TOPCARE- avobenzone 3.0% homosalate 10.0% octocrylene 6.0% lotion

Sport Sunscreen SPF 50 by

Drug Labeling and Warnings

Sport Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Topco, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                   Purpose
Avobenzone 3%.....................................Sunscreen
Homosalate 10%....................................Sunscreen
Octocrylene 6%.....................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water

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 and as needed. 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 value 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-sleeved shirts,
pants, hats, and sunglasses. Children under
6 months of age: ask a doctor.

OTHER SAFETY INFORMATION

Other information

protect the
product in this container from excessive heat
and direct sun may stain fabrics

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SUNSCREEN SPF 50  TOPCARE
avobenzone 3.0% homosalate 10.0% octocrylene 6.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-867
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
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	6 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: 36800-867-06	237 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/29/2016

Labeler - Topco (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-867) , label(36800-867)