FDA.reportPublic FDA data

WALG SUN MOISTURIZING LOTION SPF50 TUBE

Manufacturer
Walgreen Company
Effective date
2018-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:58

Label at a glance#

ProductWALG SUN MOISTURIZING SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure Re-apply: • 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 broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the ...

Storage and handling

Protect the product in this container from excessive heat and direct sun May stain fabric

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

WALGREENS 50 HYDRATING MOISTURIZING BROAD SPECTRUM SUNSCREEN SPF 50 TUBE - Avobenzone, Homosalate, Octisalate, Octocrylene Lotion

WALGREENS 50 HYDRATING MOISTURIZING BROAD SPECTRUM SUNSCREEN SPF 50 TUBE 3 FL OZ (88mL) 41419-400-WG12 (PKTB-41419-WG01)

WALGREENS 50 HYDRATING MOISTURIZING BROAD SPECTRUM SUNSCREEN SPF 50 TUBE 8 FL OZ (236mL) 41420-400-WG12 (PKTB-41420-WG01)

DRUG FACTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3% (3g/100g)

Homosalate 10% (10g/100g)

Octisalate 4.5% (4.5g/100g)

Octocrylene 8% (8g/100g)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

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 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Re-apply:
    • 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 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-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun
  • May stain fabric

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Glycerin, Polyglyceryl-3 Methylglucose Distearate, Cetearyl Alcohol, C28-52 Olefin/Undecylenic Acid Copolymer, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Diisopropyl Adipate, Phenethyl Benzoate, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-100 Stearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Polymethylsilsesquioxane, Caprylyl Glycol, Dimethicone, Fragrance, Neopentyl Glycol Diheptanoate, Hydrogenated Palm Glycerides, Trisiloxane, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Hydroxide, Disodium EDTA

Questions or comments?

OTC - QUESTIONS SECTION

1-800-925-4733

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2018 Walgreen Co.

41419-400-WG12 (PKTB-041419-WG01) REV-1118 ORG1118-F
41420-400-WG12 (PKTB-41420-WG01) REV-1118 ORG1118-F

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

50

Hydrating

Broad Spectrum SPF 50

Sunscreen UVA/UVB

HYPOALLERGENIC

OXYBENZONE FREE

PARABEN FREE

Oil free

Water resistant

(80 minutes)

3 FL OZ (88 mL)/8 FL OZ (236 mL)

Principal Display Panel Walgreens 50 Hydrating Broad Spectrum SPF 50 Sunscreen UVA/UVB HYPOALLERGENIC OXYBENZONE FREE PARABEN FREE Oil free Water resistant (80 minutes) 3 FL OZ ...Principal Display Panel Walgreens 50 Hydrating Broad Spectrum SPF 50 Sunscreen UVA/UVB HYPOALLERGENIC OXYBENZONE FREE PARABEN FREE Oil free Water resistant (80 minutes) 3 FL OZ ...

Principal Display Panel Walgreens 50 Hydrating Broad Spectrum SPF 50 Sunscreen UVA/UVB HYPOALLERGENIC OXYBENZONE FREE PARABEN FREE Oil free Water resistant (80 minutes) 3 FL OZ ...Principal Display Panel Walgreens 50 Hydrating Broad Spectrum SPF 50 Sunscreen UVA/UVB HYPOALLERGENIC OXYBENZONE FREE PARABEN FREE Oil free Water resistant (80 minutes) 3 FL OZ ...

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-8223-812020-01-31C16284748780-19d75b9d0-f8f5-f424-e053-dadaa90a57ceWALG SUN MOISTURIZING LOTION SPF50 TUBE
0363-8223-822020-01-31C16284748780-19d75b9d0-f8f5-f424-e053-dadaa90a57ceWALG SUN MOISTURIZING LOTION SPF50 TUBE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-8223-81WALG SUN MOISTURIZING SPF 5088 mL in 1 TUBELOTION881
0363-8223-82WALG SUN MOISTURIZING SPF 50236 mL in 1 TUBELOTION2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8223WALG SUN MOISTURIZING SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WALGREEN COMPANY]1Legacy NDC, 2 package rows20181227_dbda6e9b-0555-4531-8c4e-bdd8122f3ee6.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-82230363-8223-81, 0363-8223-82

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STARCH, TAPIOCA24SC3U704IIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
PHENETHYL BENZOATE0C143929GKIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PEG-100 STEARATEYD01N1999RIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE92RU3N3Y1OIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
TRISILOXANE9G1ZW13R0GIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

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
588577de-049d-4a11-a9f5-5cbc4e211f55dbda6e9b-0555-4531-8c4e-bdd8122f3ee62018-12-12WarningsExact identifier
spl id: 588577de-049d-4a11-a9f5-5cbc4e211f55
spl set id: dbda6e9b-0555-4531-8c4e-bdd8122f3ee6

Reported adverse events (FAERS/openFDA)#

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