KIDS SUNSCREEN SPF 50- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% lotion 
Wegman

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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Wegman

Drug Facts

Active ingredients                                                               Purpose
Avobenzone 3%...................................................................Sunscreen
Homosalate 15%.................................................................Sunscreen
Octisalate 5%......................................................................Sunscreen
Octocrylene 10%.................................................................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 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,
Carbomer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance,
Phenoxyethanol, Polyglyceryl-3 Distearate, Sorbitan Isostearate,
Sorbitol, Stearic Acid, Tocopherol, Triethanolamine,
VP/Eicosene Copolymer, Water

image description

KIDS SUNSCREEN SPF 50 
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47124-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Homosalate (UNII: V06SV4M95S) 15 g  in 100 mL
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Dimethicone (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)  
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:47124-112-05177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2013
Labeler - Wegman (059650069)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(47124-112) , label(47124-112)

Revised: 5/2018
Document Id: 16d06fd1-ed2d-48c3-acd9-0f7d50895c0c
Set id: 5205fcfb-069d-4745-8372-8fccb738cc58
Version: 1
Effective Time: 20180502
 
Wegman