FDA.reportPublic FDA data

Walgreens SPF55 Sunscreen Reef-Conscious Formula

Manufacturer
WALGREEN COMPANY
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:25:24

Label at a glance#

ProductWalgreens SPF55 Sunscreen Reef-Conscious Formula
Active ingredientOCTISALATE, HOMOSALATE, OCTOCRYLENE, 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 • children under 6 months of age: Ask a doctor • 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...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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 if

OTC - STOP USE SECTION

• 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 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

• children under 6 months of age: Ask a doctor

• 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

Other information

STORAGE AND HANDLING SECTION

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials, or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax (apis mellifera), lauryl laurate, ozokerite, cetearyl behenate, polybutene, butyloctyl salicylate, cetyl alcohol, styrene acrylates copolymer, myristyl myristate, theobroma cacao (cocoa) seed butter, phenoxyethanol, tocopherol, tetrahexyldecyl ascorbate

Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

W05550KW05550K

W05550EW05550E

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0976-56Walgreens SPF55 Sunscreen Reef-Conscious Formula17 g in 1 TUBESTICK174
0363-0976-57Walgreens SPF55 Sunscreen Reef-Conscious Formula34 in 1 PACKAGESTICK344

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0976WALGREENS SPF55 SUNSCREEN REEF-CONSCIOUS FORMULA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [WALGREEN COMPANY]4Current NDC, Legacy NDC, 2 package rows20241016_cfd7c1b0-cfc3-074f-e053-2995a90a5edb.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-09760363-0976-56, 0363-0976-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
OCTISALATE4X49Y0596WACTIB
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
PHENOXYETHANOLHIE492ZZ3TIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
LAURYL LAURATEGPW77G0937IACT
CERESINQ1LS2UJO3AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
WHITE WAX7G1J5DA97FIACT
CETEARYL BEHENATE7ARI9LTH0UIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
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 SPF55 Sunscreen Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYcfd7c1b0-cfc3-074f-e053-2995a90a5edb2024-10-14WarningsExact identifier
ndc (package): 0363-0976-56
ndc (package): 0363-0976-57
ndc (product): 0363-0976
ndc11 (package): 00363097656
ndc11 (package): 00363097657
spl id: 24745ddf-353c-3566-e063-6394a90af1c6
spl set id: cfd7c1b0-cfc3-074f-e053-2995a90a5edb

Reported adverse events (FAERS/openFDA)#

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