DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 - titanium dioxide and zinc oxide cream
Owen Biosciences, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients Purpose

Titanium Dioxide 10.20% Sunscreen

Zinc Oxide 3.70% Sunscreen

USES

Helps Prevent sunburn.

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

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.

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.

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 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.

main label

DERMAROLLER ANHYDROUS SUNSCREEN SPF 30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59958-201
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	10.2 g in 100 g
Zinc Oxide (Zinc Oxide)	Zinc Oxide	3.7 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone	17.5 g in 100 g
Tribehenin	1 g in 100 g
FERRIC OXIDE RED	.09 g in 100 g
FERRIC OXIDE YELLOW	.25 g in 100 g
FERROSOFERRIC OXIDE	.01 g in 100 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:59958-201-01	30 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2011

Labeler - Owen Biosciences, Inc. (790003045)

Registrant - Owen Biosciences, Inc. (790003045)

Establishment
Name	Address	ID/FEI	Operations
Owen Biosciences, Inc.		790003045	manufacture

Revised: 03/2011 Owen Biosciences, Inc.