INGENUE- zinc oxide cream

Ingenue by

Drug Labeling and Warnings

Ingenue by is a Otc medication manufactured, distributed, or labeled by Ingenue, LLC, Smith & Vandiver Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Zinc Oxide 14.5%

PURPOSE

Purpose:

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses:

Helps prevent sunburn

WARNINGS

Warnings:

• For external use only
• Do not use on damaged or broken skin.
• Stop use and ask a doctor if rash occurs.
• When using this product keep out of eyes. Rinse with water to remove.

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

INGREDIENTS AND APPEARANCE

INGENUE 
zinc oxide cream

Product 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)