Kids SPF 50

Manufacturer
TopCare | Product Quest
Effective date
2018-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:18

Label at a glance#

ProductKids SPF 50
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                                                                    Purpose
Avobenzone 3%.......................................................................................Sunscreen
Homosalate 10%.....................................................................................Sunscreen
Octisalate 5%..........................................................................................Sunscreen
Octocrylene 4%.......................................................................................Sunscreen
Oxybenzone 5%.......................................................................................Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-723-052020-01-31C16284748780-19d75b9d1-1281-f424-e053-dadaa90a57ceDrug Facts
36800-723-062020-01-31C16284748780-19d75b9d1-1281-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-723-05Kids SPF 50170 g in 1 CANSPRAY1701
36800-723-06Kids SPF 50227 g in 1 CANSPRAY2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-723KIDS SPF 50 (AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 4% OXYBENZONE 5%) SPRAY [TOPCARE]1Legacy NDC, 2 package rows20180717_298b2aa5-de4a-4507-a304-6e63dbb957f9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-72336800-723-05, 36800-723-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ef7d71b4-01e0-4228-8ac3-f9601bfcd669298b2aa5-de4a-4507-a304-6e63dbb957f92018-07-16WarningsExact identifier
spl id: ef7d71b4-01e0-4228-8ac3-f9601bfcd669
spl set id: 298b2aa5-de4a-4507-a304-6e63dbb957f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.