RxNorm Names

Not yet provided

SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER (octinoxate) lipstick
[SHISEIDO AMERICA INC.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=88e791c4-4354-4d9d-8d5a-0f281f9ea081

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

ACTIVE INGREDIENT

OCTINOXATE 4.9%

Purpose

Sunscreen

Use

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 prevent sunburn, not skin cancer or early skin aging.

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

Directions

For sunscreen use:

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

Inactive Ingredients

POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, MACADAMIA TERNIFOLIA SEED OIL, POLYETHYLENE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, MICROCRYSTALLINE WAX, EUPHORBIA CERIFERA (CANDELILLA) WAX, WATER, SODIUM MAGNESIUM SILICATE, GLYCERIN, ARGININE HCl, XYLITOL, TOCOPHERYL ACETATE, ALLANTOIN, SODIUM HYALURONATE, PEG-10 DIMETHICONE, TOCOPHEROL, DIMETHICONE, DIISOSTEARYL MALATE, BHT, METHICONE, TETRADECENE, SILICA, POLYSILICONE-2, FRAGRANCE, MICA, TITANIUM DIOXIDE, IRON OXIDES,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

SHISEIDO DIST.
NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

SHISEIDO

The Skincare

Protective
Lip Conditioner
SPF 12
SUNSCREEN

4g NET WT. .14 OZ.

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-134
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	196 mg in 4 g

Inactive Ingredients
Ingredient Name	Strength
TRIISOSTEARIN
MACADAMIA OIL
HIGH DENSITY POLYETHYLENE
DIPHENYLSILOXY PHENYL TRIMETHICONE
TRIETHYLHEXANOIN
MICROCRYSTALLINE WAX
CANDELILLA WAX
WATER
GLYCERIN
ARGININE HYDROCHLORIDE
XYLITOL
.ALPHA.-TOCOPHEROL ACETATE, DL-
ALLANTOIN
HYALURONATE SODIUM
PEG-10 DIMETHICONE (600 CST)
.ALPHA.-TOCOPHEROL
DIMETHICONE
DIISOSTEARYL MALATE
BUTYLATED HYDROXYTOLUENE
METHICONE (20 CST)
TETRADECENE
SILICON DIOXIDE
MICA
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Packaging
#	Item Code	Package Description
1	NDC:52686-134-20	1 in 1 CARTON
1		4 g in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-134), ANALYSIS(52686-134)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-134)

Revised: 09/2012

Document Id: 591e99ff-6d8d-4489-bded-c68b1c930701

Set id: 88e791c4-4354-4d9d-8d5a-0f281f9ea081

Version: 1

Effective Time: 20120917

SHISEIDO AMERICA INC.

Daily Med

Current Medication Information

Options

Additional Resources