4LIFE ENUMMI PROTECTIVE DAY MOISTURIZER SPF-15- octinoxate, octisalate, avobenzone lotion

4Life Enummi Protective Day Moisturizer by

Drug Labeling and Warnings

4Life Enummi Protective Day Moisturizer by is a Otc medication manufactured, distributed, or labeled by 4Life Research USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone  3.0%

Octinoxate   7.5%

Octisalate   2.0%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

Directions.

Apply liberally 15 minutes before sun exposure.

Apply evenly in the morning to face neck and decolletage.

Use a water resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours

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 suncreen 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.

Children under 6 months of age:   Ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients Aloe barbadensis (Aloe Vera) Leaf Juice, Ascorbyl Palmitate, Butylene Glycol, C12-15 Alkyl Benzoate, Camellia sinensis (White Tea) Leaf Extract, Caprylyl Glycol, Cetyl Alcohol, Cyclopentasiloxane, Diethylhexyl Carbonate, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate,  Hexylene Glycol, Magnesium Aluminum Silicate, Moringa pterygosperma Seed Extract, Phenoxyethanol, Phospholipids, Potassium Cetyl Phosphate, Retinyl Palmitate, Sodium Hydroxide, Tetrasodium EDTA, Tocopheryl Acetate, Transfer Factor E-CF, Water, Xanthan Gum

STORAGE AND HANDLING

Other Information Protect the product in this container from excessive heat and direct sun.

QUESTIONS

Questions of comments?

Call toll free 1-888-454-3374

GENERAL PRECAUTIONS

Protect your skin from the harsh outside world with enummi Protective Day Moisturizer infused with SPF 15.  This light and natural moisturizer blends together vitamins and other nutrients to support soft, healthy skin and promote moisture retention and resiliency.  Antioxidants protect and support younger-looking skin.  Contains Transfer Factor E-XF.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

4LIFE ENUMMI PROTECTIVE DAY MOISTURIZER  SPF-15
octinoxate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54997-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALOE (UNII: V5VD430YW9)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
BOS TAURUS COLOSTRUM (UNII: S256WJ3OFQ)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
EDETATE SODIUM (UNII: MP1J8420LU)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MORINGA OLEIFERA SEED (UNII: TIX5482832)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54997-186-02	1 in 1 CARTON	08/01/2007
1	NDC: 54997-186-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2007

Labeler - 4Life Research USA, LLC (618510226)