FDA.reportPublic FDA data

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY

Manufacturer
SHISEIDO AMERICA INC. | Davlyn Industries Inc
Effective date
2013-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:42:10

Label at a glance#

ProductSHISEIDO BENEFIANCE WRINKLERESIST24 DAY
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure10 sections

Indications and 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

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 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 sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the su...

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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS:Purpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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
  • 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 sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, SD ALCOHOL 40-B, DIPROPYLENE GLYCOL, XYLITOL, BUTYLENE GLYCOL, SILICA, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, HYDROGENATED POLYDECENE, PEG-60 GLYCERYL ISOSTEARATE, TRIISOSTEARIN, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, SAPINDUS MUKUROSSI PEEL EXTRACT, UNCARIA GAMBIR EXTRACT, SODIUM ACETYLATED HYALURONATE, HYDROXYPROLINE, THYMUS SERPILLUM EXTRACT, CHLORELLA VULGARIS EXTRACT, STEARIC ACID, GLYCERYL STEARATE SE, BEHENYL ALCOHOL, ISOSTEARIC ACID, BEHENIC ACID, BEHENETH-20, TRIETHANOLAMINE, CELLULOSE GUM, DISODIUM EDTA, SODIUM METAPHOSPHATE, ALCOHOL, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, 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 AMERICA INC.
NEW YORK, N.Y. 10022
SHISEIDO DIST.
NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 75mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

BENEFIANCE
WrinkleResist24

Day Emulsion

BROAD SPECTRUM
SPF 18

SUNSCREEN

75mL 2.5 FL. OZ.

Principal Display Panel - 75mL Bottle Carton
Principal Display Panel - 75mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-331-102023-11-28C16284748780-19d75b9d0-6787-f424-e053-dadaa90a57ceSHISEIDO BENEFIANCE WRINKLERESIST24 DAY
52686-331-112023-11-28C16284748780-19d75b9d0-6787-f424-e053-dadaa90a57ceSHISEIDO BENEFIANCE WRINKLERESIST24 DAY
52686-331-122023-11-28C16284748780-19d75b9d0-6787-f424-e053-dadaa90a57ceSHISEIDO BENEFIANCE WRINKLERESIST24 DAY
52686-331-102020-01-31C16284748780-19d75b9d0-6787-f424-e053-dadaa90a57ceSHISEIDO BENEFIANCE WRINKLERESIST24 DAY
52686-331-112020-01-31C16284748780-19d75b9d0-6787-f424-e053-dadaa90a57ceSHISEIDO BENEFIANCE WRINKLERESIST24 DAY
52686-331-122020-01-31C16284748780-19d75b9d0-6787-f424-e053-dadaa90a57ceSHISEIDO BENEFIANCE WRINKLERESIST24 DAY

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ12
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW82
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
BEHENETH-20INACTIVE INGREDIENTBJ4GP2IFLN2
BEHENIC ACIDINACTIVE INGREDIENTH390488X0A2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
CHLORELLA VULGARISINACTIVE INGREDIENTRYQ4R60M022
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C402
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB72
HYDROXYPROLINEINACTIVE INGREDIENTRMB44WO89X2
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00622
PEG-60 GLYCERYL ISOSTEARATEINACTIVE INGREDIENTWQP09739142
PEG/PPG-17/4 DIMETHYL ETHERINACTIVE INGREDIENT4ET18WJG5K2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
SAPINDUS MUKOROSSI FRUIT RINDINACTIVE INGREDIENT3D1P12PN9U2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95L2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TRIISOSTEARININACTIVE INGREDIENT71503RH8KG2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E2

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-33152686-331-10, 52686-331-11, 52686-331-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIPROPYLENE GLYCOLE107L85C40IACT
XYLITOLVCQ006KQ1EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
PEG-60 GLYCERYL ISOSTEARATEWQP0973914IACT
TRIISOSTEARIN71503RH8KGIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BEHENIC ACIDH390488X0AIACT
ISOSTEARIC ACIDX33R8U0062IACT
XANTHAN GUMTTV12P4NEEIACT
BEHENETH-20BJ4GP2IFLNIACT
TROLAMINE9O3K93S3TKIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
PEG/PPG-17/4 DIMETHYL ETHER4ET18WJG5KIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
EDETATE DISODIUM7FLD91C86KIACT
ALCOHOL3K9958V90MIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SAPINDUS MUKOROSSI FRUIT RIND3D1P12PN9UIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYDROXYPROLINERMB44WO89XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CHLORELLA VULGARISRYQ4R60M02IACT

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 9 · 496 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
DOCOSANOLDOCOSANOL9G1OE216XYAEROSOL, FOAM / TOPICAL1.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM POLYMETAPHOSPHATESODIUM POLYMETAPHOSPHATEP1BM4ZH95LSUSPENSION / ORAL1 mg/1mlExact identifier — unii candidate
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / SOFT TISSUE15 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRA-ARTICULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
2 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
704cfff1-c51b-4cd3-b6f7-1f54df79c0d0c16929c2-2903-4b4c-b451-875e332c01b82023-10-18WarningsExact identifier
spl set id: c16929c2-2903-4b4c-b451-875e332c01b8

Reported adverse events (FAERS/openFDA)#

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