Label: INGENUE- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54151-101-26 - Packager: Ingenue, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 3, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions:
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: ask a doctor
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 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses. -
INACTIVE INGREDIENT
Inactive Ingredients:
Alcohol, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, C13-14 Isoparaffin, Cyclomethicone, Glyceryl Stearate, Laureth-7, PEG-100 Stearate, Polyacrylamide, Citrullus Lanatus (Watermelon) Fruit Extract, Steareth-21, Synthetic Beeswax, Dimethicone, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Lentinus Edodes (Shiitake Mushroom) Extract, Macrocystis Pyrifera (Kelp) Extract, Pisum Sativum (Pea) Extract, Caprylyl Glycol, Castor Oil Phosphate, Sodium Benzoate, Potassium Sorbate, Annatto, Dipotassium Glycyrrhizinate, Disodium EDTA, Ferulic Acid, Maltodextrin, Phyllanthus Emblica Fruit Extract, Sodium Hyaluronate, Tetrahydro Curcuminoids, Sorbic Acid, Tetrahexyldecyl Ascorbate, Phospholipids, Retinyl Palmitate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol, Sodium Dehydroacetate, Phenoxyethanol, water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INGENUE
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54151-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-7 (UNII: Z95S6G8201) PEG-100 STEARATE (UNII: YD01N1999R) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) WATERMELON (UNII: 231473QB6R) STEARETH-21 (UNII: 53J3F32P58) SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90) DIMETHICONE (UNII: 92RU3N3Y1O) OLIVE OIL (UNII: 6UYK2W1W1E) SUNFLOWER OIL (UNII: 3W1JG795YI) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) CUCUMBER (UNII: YY7C30VXJT) CARROT (UNII: L56Z1JK48B) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) PEA (UNII: W4X7H8GYFM) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CASTOR OIL (UNII: D5340Y2I9G) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ANNATTO (UNII: 6PQP1V1B6O) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM (UNII: 7FLD91C86K) FERULIC ACID (UNII: AVM951ZWST) MALTODEXTRIN (UNII: 7CVR7L4A2D) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03) SORBIC ACID (UNII: X045WJ989B) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ASCORBYL PALMITATE (UNII: QN83US2B0N) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SOYBEAN (UNII: L7HT8F1ZOD) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54151-101-26 1 in 1 BOX 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/15/2012 Labeler - Ingenue, LLC (078662060) Establishment Name Address ID/FEI Business Operations Smith & Vandiver Corp 061973426 manufacture(54151-101)