LIP CARE SPF 15 WITH VITAMIN E- octinoxate, oxybenzone stick

LIP CARE SPF 15 WITH VITAMIN E by

Drug Labeling and Warnings

LIP CARE SPF 15 WITH VITAMIN E by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Drug Facts

Active Ingredient

Octinoxate (7.5% w/w)

Oxybenzone (5.0% w/w)

Purpose

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

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, skin cancer or early skin aging.

For external use only. 

Don not use on damaged or broken skin.

WHEN USING

When using this product

keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if

rash occurs.

PRECAUTIONS

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

Directions

Apply liberally 15 minutes before sun exposure. reapply this product at least every 2 hours. use water resistant sunscreen if swimming or sweating. children under 6 months of age: ask a doctor.

Other information

protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Ricinus Communis (Castor) Seed Oil, Hydrogenated Coconut Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Vanilla Planifolia Extract,Ammonium Glycyrrhizate, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.

Principal Display Panel

Image Components

INGREDIENTS AND APPEARANCE

LIP CARE SPF 15 WITH VITAMIN E 
octinoxate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0336
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 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
VANILLA (UNII: Q74T35078H)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0336-1	4.2 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/20/2004

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0336)