FDA.reportPublic FDA data

Chem Free SPF 30

Manufacturer
Owen Biosciences, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:31

Label at a glance#

ProductChem Free SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps protect against sunburn Higher SPF gives more sunburn protection provides moderate protection against sunburn

Dosage and administration

Apply evenly to skin before exposure to sun and as needed Reapply as needed or after towel drying or swimming Children under 6 months, ask doctor.

Label contents#

Full prescribing information#

Active Ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21.50%...... Sunscreen   

Uses

INDICATIONS & USAGE SECTION

  • Helps protect against sunburn
  • Higher SPF gives more sunburn protection
  • provides moderate protection against sunburn

Warnings

WARNINGS SECTION

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash and irritation develops and lasts. Avoid contact with eyese. If product gets into eyes, rinse thoroughly with water.  Keep out of reach of children. If swallowed, get medicl help or contact poison control center right away.

Directions

OTC - WHEN USING SECTION

  • Apply evenly to skin before exposure to sun and as needed
  • Reapply as needed or after towel drying or swimming
  • Children under 6 months, ask doctor.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Apply evenly to skin before exposure and as needed.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Purpose

OTC - PURPOSE SECTION

Sunscreen

ES SPF 30.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ES SPF 30.jpgES SPF 30.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-404-012021-07-15C16284748780-1ba0f9c33-46b3-a910-e053-dadaa90a0b85-403 Chem Free SPF 30
59958-404-012021-01-29C16284748780-1ba0f9c33-46b3-a910-e053-dadaa90a0b85-403 Chem Free SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-404-01Chem Free SPF 3050 g in 1 TUBECREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-404CHEM FREE SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]5Current NDC, Legacy NDC, 1 package rows20250114_7e5930fe-eb0f-4a21-8065-8831dd5b351c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59958-40459958-404-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

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
Chem Free SPF 30ZINC OXIDEOwen Biosciences, Inc.7e5930fe-eb0f-4a21-8065-8831dd5b351c2025-01-13WarningsExact identifier
ndc (package): 59958-404-01
ndc (product): 59958-404
ndc11 (package): 59958040401
spl id: 2b996b63-5943-0663-e063-6394a90a35f2
spl set id: 7e5930fe-eb0f-4a21-8065-8831dd5b351c

Reported adverse events (FAERS/openFDA)#

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