Label: SFL SUNSCREEN - SOL DEFENSE SPF 30- titanium dioxide, zinc oxide cream
- NDC Code(s): 59958-202-20
- Packager: Owen Biosciences Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
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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
- INFORMATION FOR PATIENTS
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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
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INGREDIENTS AND APPEARANCE
SFL SUNSCREEN - SOL DEFENSE SPF 30
titanium dioxide, zinc oxide creamProduct 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) 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 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)
