ENHANCED FACIAL MOISTURIZER- octinoxate, zinc oxide lotion

Enhanced Facial Moisturizer by

Drug Labeling and Warnings

Enhanced Facial Moisturizer by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Enhanced Facial Moisturizer

Drug Facts

Active Ingredients

Octinoxate 7.5%

Zinc Oxide 5.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

After cleansing, apply product to face and neck

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 of age: 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 am-2 pm

Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Water, Peroxidized Corn Oil, Soybean Oil, Dicaprylyl Carbonate, Polyacrylamide, C13-14 Isoparaffin, Laureth7, Steareth 21, Glycerin, Dimethicone, Myristyl Myristate, Petrolatum, Tocopheryl Acetate (Vitamin E), Panthanol (Vitamin B5), Green Tea Extract, Lactic Acid, Cetyl Alcohol, Xanthan Gum, Disodium EDTA, Steareth 2, Mica, Titanium Dioxide, BHT, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Triethoxycaprylylsilane, Propylene Glycol

Other Information

Protect this product from excessive heat and direct sun.

MANUFACTURED BY NEOTERIC COSMETICS, INC., DENVER, CO 80239

PRINCIPAL DISPLAY PANEL

Alpha
skin care
Enhanced
Facial Moisturizer
SPF 15
Net Wt. 1 oz. (28g)

INGREDIENTS AND APPEARANCE

ENHANCED FACIAL MOISTURIZER 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62673-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	.08 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.05 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)
SOYBEAN OIL (UNII: 241ATL177A)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
PETROLATUM (UNII: 4T6H12BN9U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTOTHENIC ACID (UNII: 19F5HK2737)
STEARETH-2 (UNII: V56DFE46J5)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62673-163-01	1 in 1 CARTON	01/01/2005
1		28 g 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	part352	01/01/2005

Labeler - Neoteric Cosmetics, Inc. (790615181)