FDA.reportPublic FDA data

SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2018-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:40:29

Label at a glance#

ProductSHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER
Active ingredientOCTINOXATE
Label structure11 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 4.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

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.

OTC - DO NOT USE SECTION

For external use only

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO DIST.
NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

The Skincare

Protective
Lip Conditioner
SPF 12
SUNSCREEN

4g NET WT. .14 OZ.

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton
PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-134-202023-09-25C16284748780-19d75b9d0-1504-f424-e053-dadaa90a57ceSHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER
52686-134-202020-01-31C16284748780-19d75b9d0-1504-f424-e053-dadaa90a57ceSHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW81
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ARGININE HYDROCHLORIDEINACTIVE INGREDIENTF7LTH1E20Y1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX191
DIISOSTEARYL MALATEINACTIVE INGREDIENTQBS8A3XZGQ1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPHENYLSILOXY PHENYL TRIMETHICONEINACTIVE INGREDIENTI445L28B121
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
MACADAMIA OILINACTIVE INGREDIENT515610SU8C1
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKT1
MICAINACTIVE INGREDIENTV8A1AW08801
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM01
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TETRADECENEINACTIVE INGREDIENTFW23481S7S1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIETHYLHEXANOININACTIVE INGREDIENT7K3W1BIU6K1
TRIISOSTEARININACTIVE INGREDIENT71503RH8KG1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-13452686-134-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIISOSTEARIN71503RH8KGIACT
MACADAMIA OIL515610SU8CIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CANDELILLA WAXWL0328HX19IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ARGININE HYDROCHLORIDEF7LTH1E20YIACT
XYLITOLVCQ006KQ1EIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ALLANTOIN344S277G0ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
DIMETHICONE92RU3N3Y1OIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
METHICONE (20 CST)6777U11MKTIACT
TETRADECENEFW23481S7SIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 303 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / BUCCAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYCREAM / VAGINAL23 mgExact identifier — unii candidate
4 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii candidate
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675POWDER, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
950fd18b-2fca-4f90-bcbe-61ce8d1f888b88e791c4-4354-4d9d-8d5a-0f281f9ea0812023-09-25WarningsExact identifier
spl set id: 88e791c4-4354-4d9d-8d5a-0f281f9ea081

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.