KIDS SUNSCREEN SPF 50- avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% spray

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, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                                                             Purpose

Avobenzone 3%..................................................................................Sunscreen
Homosalate 15%.................................................................................Sunscreen
Octisalate 5%......................................................................................Sunscreen
Octocrylene 10%.................................................................................Sunscreen

PURPOSE

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

WarningsFor external use only

Flammable: Do not use near heat, flme, or while smoking.
Do not use on damaged or broken skin
When using this product Keep out of eyes. Rinse eyes 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.

DOSAGE & ADMINISTRATION

Directions spray liberally and spread evenly by hand 15 minutes before sun
exposure reapply: after 80 minutes of swimming or sweating immediately after
towel drying at least every 2 hours hold container 4 to 6 inches from the skin to apply
do not spray directly into face. Spray on hands then apply to face. do not apply in
windy conditions use in a well-ventilated area
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

INACTIVE INGREDIENT

Inactive ingredients: Acrylates/Octylacrylamide, Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Stearoxytrimethylsilane, Tocopherol.

QUESTIONS

Questions?
1-800-Wegmans(934-6267) Ext 5920
9am - 4pm EST weekdays

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS SUNSCREEN SPF 50 
avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47124-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3.0   in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	15.0   in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5.0   in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	10.0   in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)
Glycerin (UNII: PDC6A3C0OX)
Stearoxytrimethylsilane (UNII: 9862TW94B2)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47124-116-10	340 g in 1 CAN; Type 0: Not a Combination Product	05/18/2018
2	NDC: 47124-116-05	170 g in 1 CAN; Type 0: Not a Combination Product	05/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/18/2018

Labeler - Wegman (059650069)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(47124-116) , label(47124-116)