FDA.reportPublic FDA data

Walgreens SPF 30 Hydrating Lotion

Manufacturer
WALGREEN COMPANY
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:24:39

Label at a glance#

ProductWalgreens SPF 30 Hydrating
Active ingredientOCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONE
Label structure12 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 value of 15 or higher and other sun protection measures including: • lim...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 3.5%

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 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 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
• children under 6 months: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• protect the product on this container from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Caprylyl Glycol, Silica, Cetyl Dimethicone, Beeswax, PPG-12/SMDI Copolymer, Ethylhexylglycerin, Dimethicone/PEG-10/15 Crosspolymer, Trilsiloxane, Ethylhexyl Stearate,Acrylates/C12-22 Alklmethacrylate Copolymer, Propylene Glycol, Behenyl Alcohol, Sodium Polyacrylate, Trideceth-6, Styrene/Acrylates Copolymer, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Xanthan Gum, Chlorphenesin, Fragrance.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

W018452A2W018452A2

W00849A2W00849A2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0146-09Walgreens SPF 30 Hydrating89 mL in 1 BOTTLELOTION892
0363-0146-14Walgreens SPF 30 Hydrating237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0146WALGREENS SPF 30 HYDRATING (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WALGREEN COMPANY]2Current NDC, 2 package rows20241013_f4155692-16a7-11e8-e053-2995a90abd34.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-01460363-0146-14, 0363-0146-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYETHYLENE GLYCOL 500761NX2Q08YIACT
TRISILOXANE9G1ZW13R0GIACT
DOCOSANOL9G1OE216XYIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
YELLOW WAX2ZA36H0S2VIACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
TRIDECETH-63T5PCR2H0CIACT
PEG-100 STEARATEYD01N1999RIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CHLORPHENESINI670DAL4SZIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB

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
Walgreens SPF 30 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf4155692-16a7-11e8-e053-2995a90abd342024-10-11WarningsExact identifier
ndc (package): 0363-0146-09
ndc (package): 0363-0146-14
ndc (product): 0363-0146
ndc11 (package): 00363014609
ndc11 (package): 00363014614
spl id: 243b0ae5-7c21-d067-e063-6294a90a081a
spl set id: f4155692-16a7-11e8-e053-2995a90abd34

Reported adverse events (FAERS/openFDA)#

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