Label: CREAM- zinc oxide cream
- NDC Code(s): 61354-112-01
- 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 July 6, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
Apply liberally 15 minutes before sun exposure.
Apply to all skin exposed to the sun.
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 the risk, regularly use a sunscreen with a board-spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear a long-sleeved shirt, pants, hat, and sunglasses
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Inactive Ingredient
Water, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglyceryl-3 Polyricinoleate, Oryza Sativa (Rice) Bran Extract, Propanediol, Caprylic/Capric Triglyceride, Glyceryl Caprylate, Coco-Caprylate/Caprate, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone, Cocos Nucifera (Coconut) Oil, Citrus Limon (Lemon) Peel Oil, Citrus Aurantofolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot)Fruit Oil, Tremella Fucformis Sporocarp Extract, Camelia Sinensis Leaf Extract, Linoleic Acid, Lecithin, Limnanther Alba (Meadowfoam (Speed Oil, Crambe Abyssinica Seed Oil, Camelia Oleifera Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil, Phytosteryl Canola Glycerides, Oleic Acid, Palmitic Acid, Stearic Acid, Triolein, Tocopherol, Adansonia Digitata Oil, Maurita Flexuosa Fruit Oil, Gardenia Taitensis Flowe Extract, Moringa Oleifera Seed Oil, Caryocar Brasiliense Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Tocopherol Acetate, Ulva Lactuca Extract, Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Triethyl Citrate, Glycerin, Betain, Glyceryl Undecylenate, Potassium Sorbate, Sodium Benzoate, Bentonite, May Contain: Titanium Dioxide (CI 77492), Iron Oxides (CI 77491, CI 77492, CI 77499)
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CREAM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.8 mg in 100 mg Inactive Ingredients Ingredient Name Strength TRICAPRYLIN (UNII: 6P92858988) 7 mg in 100 mg JOJOBA OIL (UNII: 724GKU717M) 2.76 mg in 100 mg POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) 2.04 mg in 100 mg RICE BRAN (UNII: R60QEP13IC) 2 mg in 100 mg COCO-CAPRYLATE (UNII: 4828G836N6) 1.99 mg in 100 mg POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) 1.04 mg in 100 mg DIMETHICONE (UNII: 92RU3N3Y1O) 1 mg in 100 mg TRIHEPTANOIN (UNII: 2P6O7CFW5K) 0.91 mg in 100 mg WATER (UNII: 059QF0KO0R) 28.37 mg in 100 mg STEARALKONIUM ION (UNII: UMO7T7E1XN) 2.6 mg in 100 mg BENTONITE (UNII: A3N5ZCN45C) 0.93 mg in 100 mg DODECANE (UNII: 11A386X1QH) 11.96 mg in 100 mg BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4) 3.5 mg in 100 mg GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 1.33 mg in 100 mg MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 1 mg in 100 mg PROPANEDIOL (UNII: 5965N8W85T) 2 mg in 100 mg POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) 1.2 mg in 100 mg MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 1.5 mg in 100 mg COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 1.32 mg in 100 mg TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.52 mg in 100 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1.57 mg in 100 mg FERRIC OXIDE RED (UNII: 1K09F3G675) 1.51 mg in 100 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-112-01 1 in 1 CARTON 07/06/2023 1 100 mg in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/06/2023 Labeler - Oxygen Development LLC (137098492) Establishment Name Address ID/FEI Business Operations Oxygen Development LLC 137098492 manufacture(61354-112)