FDA.reportPublic FDA data

Johnsons Baby Mineral Sunscreen Lotion SPF 30

Manufacturer
Kenvue Brands LLC
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:19

Label at a glance#

ProductJohnsons Baby Mineral Sunscreen SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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 generously and evenly 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...

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics Do not use if quality seal is broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (6.5%), Zinc Oxide (18.7%)

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously and evenly 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 of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics
  • Do not use if quality seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Isohexadecane, C12-15 Alkyl Benzoate, Ethylhexyl methoxycrylene, Behenyl Alcohol, Steareth-21, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Glyceryl Stearate, Ethylhexylglycerin, Xanthan Gum, Calcium Sodium Borosilicate, Aluminum Hydroxide, Triethoxycaprylylsilane, Cetyl Alcohol, Stearic Acid, Polyhydroxystearic Acid, Disodium EDTA, PEG-100 Stearate, Chlorphenesin, Phenoxyethanol

Questions or comments?

OTC - QUESTIONS SECTION

866-565-BABY; Outside US, dial collect 215-273-8755.

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC

Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clinically tested

safe for babies

new

Johnson’s ®

baby

SPF

30

no

more

tears ®

mineral

sunscreen

lotion

with aloe & vitamin E

for baby’s delicate skin

broad spectrum SPF 30

water resistant (80 minutes)

3.0 FL OZ (88 mL)

JohnsonsJohnsons

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130381372026622GTIN-13: 0381372026622
EAN-13: 0381372026622
GTIN-12: 381372026622
UPC-A: 381372026622
GTIN storage (14 digits): 00381372026622		Johnsons-1.jpg
QR code linkQR Code2d.kenvue.com/01/00381372026622Johnsons-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-1001-3Johnsons Baby Mineral Sunscreen SPF 3088 mL in 1 TUBELOTION881

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
69968-100169968-1001-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
CETYL ALCOHOL936JST6JCNIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
EDETATE DISODIUM7FLD91C86KIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
STEARETH-2153J3F32P58IACT
GLYCERINPDC6A3C0OXIACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT
PEG-100 STEARATEYD01N1999RIACT
CHLORPHENESINI670DAL4SZIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
ISOHEXADECANE918X1OUF1EIACT
BEHENYL ALCOHOL9G1OE216XYIACT
GLYCERYL STEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
XANTHAN GUMTTV12P4NEEIACT

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
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
ndc (package): 69968-1001-3
ndc (product): 69968-1001
ndc11 (package): 69968100103
spl id: 4fe04c4b-2752-0561-e063-6394a90af768
spl set id: 4fe04c4b-2751-0561-e063-6394a90af768

Reported adverse events (FAERS/openFDA)#

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