FDA.reportPublic FDA data

WAG Sun Baby Lotion SPF50 6oz

Manufacturer
Walgreen Company
Effective date
2017-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:59

Label at a glance#

ProductWalgreens Baby SPF50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

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 time in t...

Storage and handling

for use on skin only. Avoid contact with fabric protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

1491-23(V) Rev 01

Walgreen Baby SPF 50 Lotion

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Oxide 3.30%, Zinc Oxide 4.2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Caprylic/Capric Triglycerides, Tridecyl Neopentanoate, Sorbitol, Cetyl PEG/PPG 10/1 Dimethicone, Butly Octyl Salicylate, Glycerin, Octyldodecyl Citrate Copolymer, C28-52 Olefin/Undecylenic Acid Copolymer, PEG 8, Dimethicone, Aloe Barbadensis Leaf Juice, Ethylhexyl Methoxycrylene, Tocopherol Acetate, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Sodium Chloride, Phenoxyethanol, Sodium Citrate

Other Information

STORAGE AND HANDLING SECTION

  • for use on skin only. Avoid contact with fabric
  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

www.walgreens.com or call toll free 1-800-XX-XXXX

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens
50
Baby
Broad spectrum SPF 50
Sunscreen UVA/UVB
HYPOALLERGENIC
OXYBENZONE FREE
TEAR FREE
6 FL OZ (176 mL)

Walgreens 50 Baby Broad spectrum SPF 50 Sunscreen UVA/UVB HYPOALLERGENIC OXYBENZONE FREE TEAR FREE 6 FL OZ (176 mL)Walgreens 50 Baby Broad spectrum SPF 50 Sunscreen UVA/UVB HYPOALLERGENIC OXYBENZONE FREE TEAR FREE 6 FL OZ (176 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9936-262020-09-27C16284748780-1ab0e2407-29c1-f274-e053-dbdaa90a6471WAG Sun Baby Lotion SPF50 6oz
0363-9936-262020-09-25C16284748780-1ab0e2407-29c1-f274-e053-dbdaa90a6471WAG Sun Baby Lotion SPF50 6oz
0363-9936-262020-07-22C16284748780-1ab0e2407-29c1-f274-e053-dbdaa90a6471WAG Sun Baby Lotion SPF50 6oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9936-26Walgreens Baby SPF50178 mg in 1 BOTTLELOTION1781

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9936WALGREENS BABY SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [WALGREEN COMPANY]1Legacy NDC, 1 package rows20171115_f01975b7-e2c9-452f-992c-2ad1ecd1febc.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-99360363-9936-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TRIDECYL NEOPENTANOATE3Z8H1DA7J5IACT
SORBITOL506T60A25RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)G300307ZXPIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 8 STEARATE2P9L47VI5EIACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

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
71378623-bd71-430b-9f1c-cf4efd8da296f01975b7-e2c9-452f-992c-2ad1ecd1febc2017-08-30WarningsExact identifier
spl id: 71378623-bd71-430b-9f1c-cf4efd8da296
spl set id: f01975b7-e2c9-452f-992c-2ad1ecd1febc

Reported adverse events (FAERS/openFDA)#

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