FDA.reportPublic FDA data

Toddle Mineral SPF 50 Sunscreen 1.7 fl oz,1.3 fl oz, and 6 fl oz

Manufacturer
Toddle Born Wild, Inc. | Inspec Solutions, LLC
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:59:03

Label at a glance#

ProductSPF 50 Mineral Sunscreen Face and Body
Active ingredientZINC OXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.00%

OTC - PURPOSE SECTION

Sunscreen

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 SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

DOSAGE & ADMINISTRATION SECTION

Apply evenly to face and neck 15 minutes beofre sun exposure.

Reapply:

  • After 40 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:

  • Limin time in the sun, especially from 10a.m - 2p.m
  • Wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months:Ask a doctor.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice

Butylene Glycol

Butyloctyl Salicylate

Caprylic/Capric Triglyceride

Cetearyl Olivate

Dicaprylyl Carbonate

Dimethicone

Ethylhexyl Methoxycrylene

Ethylhexylglycerin

Helianthus Annuus (Sunflower) Seed Oil

Hydrogenated Castor Oil

Inulin

Isopropyl Myristate

Magnesium Sulfate

Niacinamide

Phenoxyethanol

Polyglyceryl-3 Polyricinoleate

Polyhydroxystearic Acid

Sorbitan Oleate

Sorbitan Olivate

Synthetic Beeswax

Tocopheryl Acetate

VP/Hexadecene Copolymer

Water

Xanthan Gum

OTC - QUESTIONS SECTION

Questions?

questions@toddleskincare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetoddleskincare.com/Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85865-002-01SPF 50 Mineral Sunscreen Face and Body50 mL in 1 TUBELOTION503
85865-002-02SPF 50 Mineral Sunscreen Face and Body100 mL in 1 TUBELOTION1003
85865-002-03SPF 50 Mineral Sunscreen Face and Body177 mL in 1 PACKAGELOTION1773

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85865-00285865-002-01, 85865-002-02, 85865-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM SULFATEDE08037SABIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN OLEATE06XEA2VD56IACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
INULINJOS53KRJ01IACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
XANTHAN GUMTTV12P4NEEIACT
SORBITAN OLIVATEMDL271E3GRIACT
CETEARYL OLIVATE58B69Q84JOIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-18monthly-update2026-06-03 17:46:18

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
SPF 50 Mineral Sunscreen Face and BodyZINC OXIDEToddle Born Wild, Inc.e97d82fe-cd45-43a5-9c1f-3900025240a12026-05-27WarningsExact identifier
ndc (package): 85865-002-02
ndc (package): 85865-002-03
ndc (package): 85865-002-01
ndc (product): 85865-002
ndc11 (package): 85865000202
ndc11 (package): 85865000201
ndc11 (package): 85865000203
spl id: 52cc5adc-9233-e0ff-e063-6394a90a227e
spl set id: e97d82fe-cd45-43a5-9c1f-3900025240a1

Reported adverse events (FAERS/openFDA)#

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