SHISEIDO CLEAR SUNSCREEN SPF 50 Plus

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:57

Label at a glance#

ProductSHISEIDO CLEAR SUNSCREEN SPF 50 Plus
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 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 reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every two 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: l...

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 ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
HOMOSALATE 10.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 10.0%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
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two 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

DIPHENYLSILOXY PHENYL TRIMETHICONE▪MINERAL OIL▪HYDROXYSTEARIC ACID▪TRIETHYLHEXANOIN▪PEG/PPG-9/2 DIMETHYL ETHER▪METHYL METHACRYLATE CROSSPOLYMER▪DIBUTYL LAUROYL GLUTAMIDE▪C12-15 ALKYL BENZOATE▪POLYAMIDE-8▪SILICA DIMETHYL SILYLATE▪TOCOPHERYL ACETATE▪PEG/PPG-14/7 DIMETHYL ETHER▪LECITHIN▪GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT▪PPG-17▪CASTOR OIL/IPDI COPOLYMER▪CAPRYLIC/CAPRIC TRIGLYCERIDE▪BHT▪TOCOPHEROL▪PEG-6▪PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE▪SILICA▪FRAGRANCE▪

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

PRINCIPAL DISPLAY PANEL - 20 g Stick Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

Clear Sunscreen Stick
50+

SynchroShield
WetForce × HeatForce

BROAD SPECTRUM
SPF 50+
For Face/Body
WATER RESISTANT
(80 MINUTES)
SUNSCREEN

BIO

RE
USE

20g NET WT. .7 OZ.

PRINCIPAL DISPLAY PANEL - 20 g Stick Pouch Label
PRINCIPAL DISPLAY PANEL - 20 g Stick Pouch Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-616-202026-01-29C16284748780-149896155-a59d-586f-e063-e6dba90add90SHISEIDO CLEAR SUNSCREEN STICK SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-616-20SHISEIDO CLEAR SUNSCREEN SPF 50 Plus1 in 1 POUCHSTICK12
58411-616-20SHISEIDO CLEAR SUNSCREEN SPF 50 Plus20 g in 1 CARTRIDGESTICK202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-616SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) STICK [SHISEIDO AMERICAS CORPORATION]2Legacy NDC, 2 package rows20241228_15a786f2-2939-4aa2-a413-b661ff6d2dd9.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-61658411-616-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

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
a91c180a-3d45-4943-ab1a-b8ca86dc997615a786f2-2939-4aa2-a413-b661ff6d2dd92024-12-23WarningsExact identifier
spl id: a91c180a-3d45-4943-ab1a-b8ca86dc9976
spl set id: 15a786f2-2939-4aa2-a413-b661ff6d2dd9

Reported adverse events (FAERS/openFDA)#

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