CREAM OIL SUNSCREEN- zinc oxide, titanium dioxide sunscreen cream

Cream Oil Sunscreen by

Drug Labeling and Warnings

Cream Oil Sunscreen by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients Purpose

Zinc Oxide 21.50%...... Sunscreen

Titanium Dioxide 1.25%...... Sunscreen

Uses

Helps protect against sunburn
provides moderate protection against sunburn

Warnings

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

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

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

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CREAM OIL SUNSCREEN 
zinc oxide, titanium dioxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)	32.6 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-408-02	1 in 1 CARTON	04/04/2020
1	NDC: 59958-408-01	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/04/2020

Labeler - Owen Biosciences, Inc. (790003045)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences, Inc.		790003045	manufacture(59958-408)