FDA.reportPublic FDA data

MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL-BASED SUNSCREEN LOTION

Manufacturer
MEIJER DISTRIBUTION INC
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:26:24

Label at a glance#

ProductMEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREEN
Active ingredientZINC OXIDE, OCTISALATE, OCTINOXATE
Label structure12 sections

Indications and uses

helps prevent sunburn if used as directed with othersun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging casued 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 value of 15 or higher and other sun pr...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 14.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Other information

OTHER SAFETY INFORMATION

  • 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

water, propylene glycol, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, OEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf juice, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

M68494M68494

M68495M68495

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-362-71MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREEN177 mL in 1 BOTTLELOTION1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-362MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREEN (OCTINOXATE, OCTISALATE, ZINC OXIDE) LOTION [MEIJER DISTRIBUTION INC]4Current NDC, Legacy NDC, 1 package rows20241018_a9f4fd45-3bbb-14a7-e053-2995a90ab28f.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
41250-36241250-362-71

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
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYL PALMITATE2865993309IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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 KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDEMEIJER DISTRIBUTION INCa9f4fd45-3bbb-14a7-e053-2995a90ab28f2024-10-16WarningsExact identifier
ndc (package): 41250-362-71
ndc (product): 41250-362
ndc11 (package): 41250036271
spl id: 249b0894-c5a1-5135-e063-6394a90a3ef6
spl set id: a9f4fd45-3bbb-14a7-e053-2995a90ab28f

Reported adverse events (FAERS/openFDA)#

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