SUNSCREEN SPORT SPF 50 GOOD SENSE- avobenzone 3.0% homosalate 10.0% octocrylene 6.0% lotion 
Good Sense

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 information

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

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.

image description

SUNSCREEN SPORT SPF 50  GOOD SENSE
avobenzone 3.0% homosalate 10.0% octocrylene 6.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-772
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate10 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-772-06237 mL in 1 CONTAINER; Type 0: Not a Combination Product03/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/29/2018
Labeler - Good Sense (076059836)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(50804-772) , label(50804-772)

Revised: 5/2018
Document Id: 70c6f8c1-1009-4a61-aa3b-fedf81c21f21
Set id: 1824cf1d-3155-4c41-8ea9-63aaa64cde69
Version: 1
Effective Time: 20180516
 
Good Sense