Zinc Oxide 20%

Manufacturer
The Soleil Group, LLC | Inspec Solutions
Effective date
2026-03-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:04

Label at a glance#

ProductZinc Oxide 20%
Active ingredientZINC OXIDE
Label structure6 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 evenly to face and neck 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 includin...

Label contents#

Full prescribing information#

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply evenly to face and neck 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
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.

Warnings For external use only.

WARNINGS SECTION

Do not useon damaged or broken skin.
When using this product• keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice,
Aluminum Starch Octenylsuccinate,
Bisabolol,
Caprylic/Capric Triglyceride,
Capryloyl Glycerin/Sebacic Acid Copolymer,
Caprylyl Carbonate,
Diheptyl Succinate,
Ethylhexylglycerin,
Galactoarabinan,
Glycerin,
Glyceryl Stearate SE,
Helianthus Annuus (Sunflower) Seed Oil,
Jojoba Esters,
Magnesium Sulfate,
Mica,
Niacinamide,
Octyldodecanol,
Phenoxyethanol,
Polyglyceryl-2 Distearate,
Polyhydroxystearic Acid,
Porphyra Umbilicalis Extract,
Sodium Hyaluronate,
Squalane Oil,
Tetrahexyldecyl Ascorbate,
Tocopheryl Acetate,
Triethoxycaprylylsilane,
Trihydroxystearin,
Tripeptide-5,
VP/Hexadecene Copolymer,
Water,
Iron Oxide Red (CI 77491),
Tin Oxide (CI 77861),
Titanium Dioxide (CI 77891)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69630-004-01Zinc Oxide 20%1 in 1 CARTONLOTION12
69630-004-01Zinc Oxide 20%16 mL in 1 BOTTLELOTION162

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69630-00469630-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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
Zinc Oxide 20%SUNSCREEN SPF 50The Soleil Group, LLC27d20573-0b6b-4d4b-94ca-69b476a883a72026-03-23WarningsExact identifier
ndc (package): 69630-004-01
ndc (product): 69630-004
ndc11 (package): 69630000401
spl id: 4db2b8a1-b627-9f7b-e063-6394a90a1fa9
spl set id: 27d20573-0b6b-4d4b-94ca-69b476a883a7

Reported adverse events (FAERS/openFDA)#

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