Baby Gentle Sunscreen SPF 50

Manufacturer
TopCo | Product Quest Mfg.
Effective date
2018-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:56

Label at a glance#

ProductBaby Gentle Sunscreen SPF 50
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure7 sections

Dosage and administration

• apply liberally 15 minutes before sun exposure • 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 of 15 or higher and other sun protection measures including: • limit ti...

Label contents#

Full prescribing information#

Active ingredients                         Purpose

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%..........................Sunscreen
Homosalate 13.0%.........................Sunscreen
Octisalate 5.0%..............................Sunscreen
Octocrylene 7.0%...........................Sunscreen
Oxybenzone 4.0%..........................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 high protection against sunburn

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure
• 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 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

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 \

Aluminum Starch
Octenylsuccinate, Benzyl Alcohol, Carbomer, Dimethicone,
Disodium EDTA, Fragrance, Methylparaben, Polyglyceryl-3
Distearate, Propylparaben, Sorbitan Isostearate, Sorbitol, Stearic
Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800186538GTIN-13: 0036800186538
EAN-13: 0036800186538
GTIN-12: 036800186538
UPC-A: 036800186538
GTIN storage (14 digits): 00036800186538
label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-870-062020-01-31C16284748780-19d75b9d0-2569-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-870-06Baby Gentle Sunscreen SPF 50237 mL in 1 BOTTLELOTION2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-870BABY GENTLE SUNSCREEN SPF 50 (AVOBENZONE - 3.0% HOMOSALATE - 13.0% OCTISALATE - 5.0% OCTOCRYLENE - 7.0% OXYBENZONE 4%) LOTION [TOPCO]1Legacy NDC, 1 package rows20180615_94a11f26-2de6-446f-8122-d82b2d64f5ee.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-87036800-870-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
3bd2fe9a-0748-43ea-b372-72b52a39851294a11f26-2de6-446f-8122-d82b2d64f5ee2018-06-15WarningsExact identifier
spl id: 3bd2fe9a-0748-43ea-b372-72b52a398512
spl set id: 94a11f26-2de6-446f-8122-d82b2d64f5ee

Reported adverse events (FAERS/openFDA)#

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