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

Kids Sunscreen SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Active ingredients                                                               Purpose
Avobenzone 3%...................................................................Sunscreen
Homosalate 15%.................................................................Sunscreen
Octisalate 5%......................................................................Sunscreen
Octocrylene 10%.................................................................Sunscreen

INDICATIONS & USAGE

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

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,
Carbomer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance,
Phenoxyethanol, Polyglyceryl-3 Distearate, Sorbitan Isostearate,
Sorbitol, Stearic Acid, Tocopherol, Triethanolamine,
VP/Eicosene Copolymer, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47124-112
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
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47124-112-05	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2013

Labeler - Wegman (059650069)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(47124-112) , label(47124-112)