Label: CREAM- titanium dioxide cream
- NDC Code(s): 61354-080-06, 61354-080-12
- Packager: Oxygen Development LLC
- 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 February 10, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using
- Stop use
- Keep out of reach of children
- Directions
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Sun protection measures
spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am - 2pm
- wear long-slevve shirts, pants, hats, and sunglasses
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Inactive ingredients
isododecane, disteardimonium hectorite, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, propylene carbonate, silica, Trimethylsiloxysilicate, Dipalmitoyl Hydroxyproline, Mangifera Indica (Mango) Seed Butter, Carthamus Tinctorius (Safflower) Seed Oil, Camellia Oleifera Leaf Extract, Acrylates Copolymer, Diacetyl Boldine, Calcium Sodium Borosilicate, Calcium Aluminum Borosilicate, tin oxide, phenoxyethanol, may contain: mica, carmine, titanium dioxide, iron oxides, Bismuth Oxychloride,chromium hydroxide green, chromium oxide greens, ferric fenocyanide, manganese violet, ultramarines
- other information
- package label
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INGREDIENTS AND APPEARANCE
CREAM
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 17 mg in 100 mg Inactive Ingredients Ingredient Name Strength TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) MANGO SEED OIL (UNII: K8LOR30915) ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) ISODODECANE (UNII: A8289P68Y2) MICA (UNII: V8A1AW0880) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-080-12 1 in 1 CARTON 02/22/2021 02/10/2023 1 NDC:61354-080-06 3 mg in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/22/2021 Labeler - Oxygen Development LLC (137098492) Establishment Name Address ID/FEI Business Operations Oxygen Development LLC 137098492 manufacture(61354-080)