INGENUE - zinc oxide cream 
Ingenue, LLC

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.

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Drug Facts

Active Ingredient:

Zinc Oxide 14.5%

Purpose:

Sunscreen

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Uses:

Helps prevent sunburn

Warnings:


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 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.

image

INGENUE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54151-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54151-101-261 in 1 BOX
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/15/2012
Labeler - Ingenue, LLC (078662060)
Establishment
NameAddressID/FEIBusiness Operations
Smith & Vandiver Corp061973426manufacture(54151-101)

Revised: 12/2012
Document Id: 78c157ec-598d-4916-9cf2-7e9619f26ca0
Set id: 018c7150-ac31-4376-a769-d35ea7456bcd
Version: 1
Effective Time: 20121203
 
Ingenue, LLC