FDA Label for Dermaroller Anhydrous Sunscreen Spf 30

View Indications, Usage & Precautions

Dermaroller Anhydrous Sunscreen Spf 30 Product Label

The following document was submitted to the FDA by the labeler of this product Owen Biosciences, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredients                  Purpose

Titanium Dioxide 10.20%        Sunscreen

Zinc Oxide 3.70%                  Sunscreen


Otc - Purpose



USES

Helps Prevent sunburn.

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.


Warnings



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



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



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



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




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