LIP CONDITIONER SPF 15 MERLE NORMAN- octinoxate,octisalate jelly

Lip Conditioner SPF 15 by

Drug Labeling and Warnings

Lip Conditioner SPF 15 by is a Otc medication manufactured, distributed, or labeled by Merle Norman. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients           Purpose

OCTINOXATE 7.5%      Sunscreen

OCTISALATE 5.0%       Sunscreen

Uses
· helps prevent sunburn

· Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

· Stop use and ask a doctor if rash occurs and persists

WARNINGS
Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Directions
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months of age: Ask a doctor

Inactive

Ricinus communis ( castor) seed oil, macadamia ternifolia seed oil, ozokerite, euphorbia cerifera ( candelilla) wax, copernicia cerifera ( carnauba) wax, astrocaryum murumuru seed butter, isopropyl lanolate, jojoba esters, wheat germ glycerides, oleyl alcohol, isodecyl oleate, butyspermum parkii (shea ) butter, elaeis guineensis (palm) butter, punica granatum extract, acacia decurrens flower wax, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed wax, jojoba oil, c12-15 alkyl benzoate, polyglyceryl-3 esters, polyhydroxystearic acid, stearic acid, BHT, aluminum oxide, titanium dioxide, Fragrance (parfum) 030411

PRINCIPAL DISPLAY PANEL

Lip Conditioner

SPF 15

Merle Norman

3.7 g net. wt. .13 oz.

INGREDIENTS AND APPEARANCE

LIP CONDITIONER SPF 15  MERLE NORMAN
octinoxate,octisalate jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	.278 g  in 3.7 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	.185 g  in 3.7 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
MACADAMIA OIL (UNII: 515610SU8C)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
SHEA BUTTER (UNII: K49155WL9Y)
ELAEIS GUINEENSIS FRUIT BUTTER (UNII: UYH3R74N56)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-107-02	1 in 1 CARTON	04/21/2011
1	NDC: 57627-107-01	3.7 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 not final	part352	04/21/2011

Labeler - Merle Norman (008479388)

Registrant - Merle Norman (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman		008479388	manufacture(57627-107)