FDA.reportPublic FDA data

MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN LOTION

Manufacturer
MEIJER DISTRIBUTION, INC.
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:26:24

Label at a glance#

ProductMEIJER BROAD SPECTRUM SPF 50 SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure11 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 hig...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

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 • 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

OTC - STOP USE SECTION

• 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

• 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

OTHER SAFETY INFORMATION

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics/materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN LOTION

8 FL OZ (237mL)

NDC 41250-561-11

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-561-11MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-561MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [MEIJER DISTRIBUTION, INC.]2Current NDC, Legacy NDC, 1 package rows20241018_a71bf24f-b923-b81f-e053-2995a90a0072.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-56141250-561-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
CARBOMER 934Z135WT9208IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
POLYETHYLOXAZOLINE (200000 MW)I765I75FT2IACT
DIMETHICONE92RU3N3Y1OIACT
TOCOPHEROLR0ZB2556P8IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
BENZYL ALCOHOLLKG8494WBHIACT
TROLAMINE9O3K93S3TKIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
PROPYLPARABENZ8IX2SC1OHIACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
OXYBENZONE95OOS7VE0YACTIB

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
MEIJER BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMEIJER DISTRIBUTION, INC.a71bf24f-b923-b81f-e053-2995a90a00722024-10-16WarningsExact identifier
ndc (package): 41250-561-11
ndc (product): 41250-561
ndc11 (package): 41250056111
spl id: 249af36e-cbfd-7280-e063-6394a90a07ec
spl set id: a71bf24f-b923-b81f-e053-2995a90a0072

Reported adverse events (FAERS/openFDA)#

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