FDA.reportPublic FDA data

cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:46:18

Label at a glance#

Productcle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n
Active ingredientAVOBENZONE, OCTINOXATE, 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 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 ingredientsPurpose
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 useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif 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•BUTYLENE GLYCOL•DIPROPYLENE GLYCOL•PENTAERYTHRITYL TETRAETHYLHEXANOATE•DIPHENYLSILOXY PHENYL TRIMETHICONE•BEHENYL ALCOHOL•GLYCERYL DIISOSTEARATE•BEHENETH-20•XYLITOL•SILICA•BETAINE•DIMETHICONE•SD ALCOHOL 40-B•PEG/PPG-14/7 DIMETHYL ETHER•XANTHAN GUM•TOCOPHERYL ACETATE•POLYQUATERNIUM-51•DIPEPTIDE-15•ERYTHRITOL•PEG/PPG-17/4 DIMETHYL ETHER•LAURYL BETAINE•CENTAUREA CYANUS FLOWER EXTRACT•LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT•MORUS ALBA ROOD EXTRACT•SODIUM ACETYLATED HYALURONATE•SODIUM HYALURONATE•MELISSA OFFICINALIS LEAF EXTRACT•LECITHIN•NUPHAR JAPONICUM ROOT EXTRACT•ZINGIBER AROMATICUS EXTRACT•PANAX GINSENG ROOT EXTRACT•CAMELLIA SINENSIS LEAF EXTRACT•GINKGO BILOBA LEAF EXTRACT•BUPLEURUM FALCATUM ROOT EXTRACT•PPG-17•STEARYL ALCOHOL•MYRISTYL MYRISTATE•ALCOHOL•CARBOMER•POTASSIUM HYDROXIDE•ISOSTEARIC ACID•SODIUM METAPHOSPHATE•DISODIUM EDTA•BHT•SODIUM METABISULFITE•CINNAMOMUM CASSIA BARK EXTRACT•TOCOPHEROL•PHENOXYETHANOL•METHYLPARABEN•SODIUM BENZOATE•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

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SYNACTIF

Daytime
moisturizer
enriched

BROAD SPECTRUM
SPF 19
SUNSCREEN

clé de peau
BEAUTÉ

20mL NET WT. .7 OZ.

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-889-40cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n20 mL in 1 BOTTLEEMULSION202

Products#

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

DailyMed product names page 1 of 2 · 59 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-88958411-889-40

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 57 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PENTAERYTHRITYL TETRAETHYLHEXANOATEXJ7052W897IACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL DIISOSTEARATE68BAV42LRCIACT
BEHENETH-20BJ4GP2IFLNIACT
XYLITOLVCQ006KQ1EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BETAINE3SCV180C9WIACT
DIMETHICONE92RU3N3Y1OIACT
ALCOHOL3K9958V90MIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JIACT
DIGLYCINE10525P22U0IACT
ERYTHRITOLRA96B954X6IACT
PEG/PPG-17/4 DIMETHYL ETHER4ET18WJG5KIACT
LAURYL BETAINEY4P927Q133IACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
LAMIUM ALBUM FLOWER62IB9494JAIACT
MORUS ALBA ROOTCST1G9BZGDIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
HYALURONATE SODIUMYSE9PPT4THIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
NUPHAR JAPONICA ROOT3OPM78C6RQIACT
GINGERC5529G5JPQIACT
ASIAN GINSENGCUQ3A77YXIIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GINKGO19FUJ2C58TIACT
BUPLEURUM FALCATUM ROOTX04E310LUYIACT
PPG-17OV0Q322E0UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT

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
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
ndc (package): 58411-889-40
ndc (product): 58411-889
ndc11 (package): 58411088940
spl id: 4b07883d-d6da-748e-e063-6294a90a9ccf
spl set id: f3729d0b-e601-48bb-9907-1d6e3ab31996

Reported adverse events (FAERS/openFDA)#

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