KIDS SPF 50- avobenzone 3% homosalate 10% octisalate 5% octocrylene 4% oxybenzone 5% spray

Kids SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                                    Purpose
Avobenzone 3%.......................................................................................Sunscreen
Homosalate 10%.....................................................................................Sunscreen
Octisalate 5%..........................................................................................Sunscreen
Octocrylene 4%.......................................................................................Sunscreen
Oxybenzone 5%.......................................................................................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
moderate protection against sunburn

WARNINGS

Warnings
Flammable: Do not use near heat, flame, or while smoking.
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 or irritation develops and last

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do
not store at temperature above 120°F

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.
Children under 6 months of age: ask a doctor. 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. 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. For
sunscreen use: apply to all skin exposed to the sun. Reapply as needed or after
towel drying, swimming, or sweating.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS SPF 50 
avobenzone 3% homosalate 10% octisalate 5% octocrylene 4% oxybenzone 5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-723
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 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	10 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	4 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)
Glycerin (UNII: PDC6A3C0OX)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-723-05	170 g in 1 CAN; Type 0: Not a Combination Product	02/15/2016
2	NDC: 36800-723-06	227 g in 1 CAN; Type 0: Not a Combination Product	02/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/15/2016

Labeler - TopCare (006935977)

Registrant - Product Quest (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest		927768135	manufacture(36800-723) , label(36800-723)