BABY GENTLE SUNSCREEN SPF 50- avobenzone - 3.0% homosalate - 13.0% octisalate - 5.0% octocrylene - 7.0% oxybenzone 4% lotion 
TopCo

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 3.0%..........................Sunscreen
Homosalate 13.0%.........................Sunscreen
Octisalate 5.0%..............................Sunscreen
Octocrylene 7.0%...........................Sunscreen
Oxybenzone 4.0%..........................Sunscreen

Uses • helps prevent sunburn • higher SPF gives more
sunburn protection • retains SPF after 80 minutes of activity in
the water or sweating • provides high protection against sunburn

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

Inactive ingredients \

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

Questions? 1-888-423-0139

image description

BABY GENTLE SUNSCREEN SPF 50 
avobenzone - 3.0% homosalate - 13.0% octisalate - 5.0% octocrylene - 7.0% oxybenzone 4% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-870
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) Octocrylene7 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
Benzyl Alcohol (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
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)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-870-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/21/2016
Labeler - TopCo (006935977)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(36800-870) , label(36800-870)

Revised: 6/2018
Document Id: 3bd2fe9a-0748-43ea-b372-72b52a398512
Set id: 94a11f26-2de6-446f-8122-d82b2d64f5ee
Version: 1
Effective Time: 20180615
 
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