SFL SUNSCREEN - SOL DEFENSE SPF 30- titanium dioxide, zinc oxide cream

SFL SUNSCREEN - SOL DEFENSE by

Drug Labeling and Warnings

SFL SUNSCREEN - SOL DEFENSE by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients                  Purpose

Titanium Dioxide 10.20%        Sunscreen

Zinc Oxide 3.70%                  Sunscreen

PURPOSE

USES

Helps protect against 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.

Avoid contact with eyes. If product gets into eyes,
rinse thoroughly with water.

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

INDICATIONS & USAGE

Directions

Apply generously before sun exposure and as
needed. For children under 6 months, 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SFL SUNSCREEN - SOL DEFENSE  SPF 30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	10.2 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone (UNII: NMQ347994Z)	17.5 g  in 100 g
Tribehenin (UNII: 8OC9U7TQZ0)	1 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675)	.09 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	.25 g  in 100 g
FERROSOFERRIC OXIDE (UNII: XM0M87F357)	.01 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-202-20	60 g in 1 TUBE; Type 0: Not a Combination Product	09/11/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/11/2012

Labeler - Owen Biosciences Inc. (790003045)