FDA.reportPublic FDA data

Anhydrous SPF 30

Manufacturer
Owen Biosciences, Inc.
Effective date
2022-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:20

Label at a glance#

ProductAnhydrous SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                  Purpose

Titanium Dioxide 10.20%        Sunscreen

Zinc Oxide 3.70%                  Sunscreen

OTC - PURPOSE SECTION

USES

Helps Prevent sunburn.

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

WARNINGS SECTION

Warnings

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.  Keep out of reach of

children. If swallowed, get medical help or

contact poison control center right away.

INDICATIONS & USAGE SECTION

Directions

Apply evenly before sun exposure and as

needed.  For children under 6 months of age: ask

a doctor.  Reapply as needed or after towel

drying, swimming or perspiring.

INFORMATION FOR PATIENTS SECTION

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

harmful effects of the sun.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Master LabelMaster Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-200-012025-01-30C16284748780-1956f9ecf-c0cc-621f-e053-dbdaa90a74adOwen Biosciences Drug Facts Anhydrous SPF 30
59958-200-012022-04-22C16284748780-1956f9ecf-c0cc-621f-e053-dbdaa90a74adOwen Biosciences Drug Facts Anhydrous SPF 30
59958-200-012019-10-21C16284748780-1956f9ecf-c0cc-621f-e053-dbdaa90a74adOwen Biosciences Drug Facts Anhydrous SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-200-01Anhydrous SPF 30100000 g in 1 DRUMCREAM1000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-200ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2Current NDC, Legacy NDC, 1 package rows20220423_6f56e04f-6d90-41e4-976e-e2e98dfbc98c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1

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
59958-20059958-200-01

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
CYCLOMETHICONENMQ347994ZIACT
TRIBEHENIN8OC9U7TQZ0IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
ndc (product): 59958-200
dd449031-7973-e899-e053-2a95a90a0f4d6f56e04f-6d90-41e4-976e-e2e98dfbc98c2022-04-22WarningsExact identifier
spl id: dd449031-7973-e899-e053-2a95a90a0f4d
spl set id: 6f56e04f-6d90-41e4-976e-e2e98dfbc98c
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.1510cae2-9c8f-45ba-b088-67747af3d30c2021-07-15WarningsExact identifier
ndc (product): 59958-200

Reported adverse events (FAERS/openFDA)#

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