Label at a glance#

ProductCream Oil Sunscreen

Active ingredientZINC OXIDE, TITANIUM DIOXIDE

Label structure9 sections

Indications and uses

Helps protect against sunburn provides moderate protection against sunburn

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: ask doctor. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 s...

Label contents#

Full prescribing information#

Active Ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21.50%...... Sunscreen

Titanium Dioxide 1.25%...... Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps protect against sunburn
provides moderate protection against sunburn

Warnings

WARNINGS SECTION

Do not use on damaged or broken skin

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

Stop use and ask doctor if rash occurs

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

OTC - WHEN USING SECTION

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: ask doctor.
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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.
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating

Other Information

OTHER SAFETY INFORMATION

Protect the product in this contianer from heat and direct sun.

DOSAGE & ADMINISTRATION SECTION

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

RECENT MAJOR CHANGES SECTION

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

OTC - PURPOSE SECTION

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59958-408-01	Cream Oil Sunscreen	50 g in 1 TUBE	CREAM	50		4
59958-408-02	Cream Oil Sunscreen	1 in 1 CARTON	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59958-408	CREAM OIL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN) CREAM [OWEN BIOSCIENCES, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20241107_b2ccdfea-1c27-42af-b9d8-752e9f91ae87.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Cream Oil Sunscreen
Zinc Oxide, Titanium Dioxide Sunscreen
WATER
ZINC OXIDE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59958-408	59958-408-01, 59958-408-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cream Oil Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	Owen Biosciences, Inc.	b2ccdfea-1c27-42af-b9d8-752e9f91ae87	2024-11-05	Warnings	Exact identifier ndc (package): 59958-408-01 ndc (package): 59958-408-02 ndc (product): 59958-408 ndc11 (package): 59958040802 ndc11 (package): 59958040801 spl id: 2630ac67-a827-30c9-e063-6394a90a3561 spl set id: b2ccdfea-1c27-42af-b9d8-752e9f91ae87

Reported adverse events (FAERS/openFDA)#

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