KIDS SUNSCREEN SPF 50- avobenzone 3% homosalate 13% octisalate 5% octocrylene 2% oxybenzone 4% lotion 
Gator Saver

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 - 3.00%           sunscreen
Homosalate - 13.00%          sunscreen
Octisalate - 5.00%               sunscreen
Octocrylene - 2.00%            sunscreen
Oxybenzone - 4.00%           sunscreen

Uses

Helps prevent sunburn

Direction

• Hold container 4-6 inches from skin to apply.
• Spray liberally and spread evenly by hands 15 minutes before sun exposure
• Do not spray directly into face. Spray on hands then apply to face.
• Do not apply in windy conditions. Use in well-ventilated area.

• 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 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 month: Ask a doctor

Warnings
For external use only

Flammable. Keep away from fire or flame

Do not use on damage or broken skin

When using this product avoid contact with eyes. Rinse with water to remove. Keep away from face to avoid breathing it.

Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F

Stop use and ask a doctor if rash occurs

Keep out of reach of the children

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

Inactive ingredients

Acrylates / C10-30 Alkyl Acrylate Crosspolymer
Benzyl Alcohol
Dimethicone
Disodium EDTA
Fragrance
Methylparaben
Polyglyceryl-3 Distearate
Propylparaben
Sorbitan Isostearate
Sorbitol
Stearic Acid
Styrene / Acrylates Copolymer
Tocopherol
Triethanolamine
VP / Eicosene Copolymer
Water

image description

KIDS SUNSCREEN SPF 50 
avobenzone 3% homosalate 13% octisalate 5% octocrylene 2% oxybenzone 4% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70855-704
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) Homosalate13 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Benzyl Alcohol (UNII: LKG8494WBH)  
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)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
Tocopherol (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70855-704-05177 mL in 1 CAN; Type 0: Not a Combination Product05/31/201611/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/31/201611/07/2017
Labeler - Gator Saver (088201460)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(70855-704) , label(70855-704)

Revised: 11/2017
Document Id: 819def94-daf6-4ea0-9a22-95c54417e0d5
Set id: 82ad8569-2026-430b-bb93-c75ff5c6299e
Version: 2
Effective Time: 20171107
 
Gator Saver