SFL SUNSCREEN - SOL DEFENSE  SPF 30- titanium dioxide, 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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SFL Sunscreen - SOL Defense

Drug Facts

Active ingredients                  Purpose

Titanium Dioxide 10.20%        Sunscreen

Zinc Oxide 3.70%                  Sunscreen

USES

Helps protect against 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.

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.

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.


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.

image description

SFL SUNSCREEN - SOL DEFENSE   SPF 30
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10.2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z) 17.5 g  in 100 g
TRIBEHENIN (UNII: 8OC9U7TQZ0) 1 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) 0.09 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.25 g  in 100 g
FERROSOFERRIC OXIDE (UNII: XM0M87F357) 0.01 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-202-2060 g in 1 TUBE; Type 0: Not a Combination Product09/11/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/11/2012
Labeler - Owen Biosciences Inc. (790003045)

Revised: 1/2023
Document Id: f2682ce3-8cf9-df80-e053-2a95a90ac08a
Set id: 4382d55d-1463-41e3-9805-4125055b2e42
Version: 6
Effective Time: 20230116
 
Owen Biosciences Inc.