Label: SUNSCREEN- titanium dioxide 6.8% liquid
- NDC Code(s): 84203-001-01
- Packager: Baxter of California, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 23, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including
- limit time in the sun, especially from 10am-2pm
- wear long sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
water, undecane, dimethicone, glycerin, tridecane, polyglyceryl-4 isostearate, pentylene
glycol, cetyl PEG/PPG-10/1, hexyl laurate, magnesium sulfate, disteardimonium hectorite,
trihydroxystearin, cellulose gum, aluminum hydroxide, disodium stearoyl glutamate,
acetylated glycol stearate, acrylates copolymer, ethylhexylglyceerin; may contain:
titanium dioxide, iron oxides - Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN
titanium dioxide 6.8% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84203-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.068 g in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) UNDECANE (UNII: JV0QT00NUE) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) TRIDECANE (UNII: A3LZF0L939) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PENTYLENE GLYCOL (UNII: 50C1307PZG) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) HEXYL LAURATE (UNII: 4CG9F9W01Q) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ACETYLATED GLYCOL STEARATE (UNII: K71M6R9N7E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84203-001-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 03/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/25/2024 Labeler - Baxter of California, LLC (031183172) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising, Inc 076693183 manufacture(84203-001)
