FDA.reportPublic FDA data

cle de peau BEAUTE THE FOUNDATION N M

Manufacturer
Shiseido Americas Corporation | Shiseido America Inc.
Effective date
2026-02-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:47:15

Label at a glance#

Productcle de peau BEAUTE THE FOUNDATION N M BF10
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure27 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 i...

Storage and handling

protect this product in this container from excessive heat and direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active IngredientsPurpose
Octinoxate 3.9%Sunscreen 
Titanium Dioxide 3.3% 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 INGREDIENT SECTION

WATER･DIMETHICONE･BUTYLENE GLYCOL･GLYCERIN･CETYL ETHYLHEXANOATE･CETYL PEG/PPG-10/1 DIMETHICONE･NEOPENTYL GLYCOL DIHEPTANOATE･DIPHENYLSILOXY PHENYL TRIMETHICONE･TREHALOSE･TOCOPHERYL ACETATE･ARGANIA SPINOSA KERNEL OIL･SODIUM HYALURONATE･SODIUM DILAURAMIDOGLUTAMIDE LYSINE･MAGNESIUM CHLORIDE･PISTACIA LENTISCUS (MASTIC) GUM･GLYCINE･PEG/PPG-14/7 DIMETHYL ETHER･BUPLEURUM FALCATUM ROOT EXTRACT･ZANTHOXYLUM PIPERITUM PEEL EXTRACT･THYMUS SERPYLLUM EXTRACT･SODIUM ACETYLATED HYALURONATE･ROSA ROXBURGHII FRUIT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDROLYZED SILK･PERILLA OCYMOIDES LEAF EXTRACT･DEXTRIN PALMITATE･PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･ALUMINUM HYDROXIDE･STEARIC ACID･TRISODIUM EDTA･HYDROXYPROPYLCELLULOSE･PALMITIC ACID･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･ALCOHOL･DISTEARYLDIMONIUM CHLORIDE･TRIETHOXYCAPRYLYLSILANE･SYNTHETIC FLUORPHLOGOPITE･BARIUM SULFATE･CAPRYLIC/CAPRIC TRIGLYCERIDE･ISOPROPYL ALCOHOL･BHT･SILICA･THEANINE･PHENOXYETHANOL･CHLORPHENESIN･FRAGRANCE･TITANIUM DIOXIDE･IRON OXIDES･

Other Information

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sunlight

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

O50O50

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - I10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

I10I10

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 O10O10OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

O20O20

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

O30O30

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

O40O40

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

O60O60

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O80

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

O80O80

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

O100O100

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

B10B10

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

B20B20

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

B30B30

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

B40B40

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

B50B50

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - BF10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

BF10BF10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-001-10cle de peau BEAUTE THE FOUNDATION N MO201 in 1 BOXPASTE12
58411-001-10cle de peau BEAUTE THE FOUNDATION N MO2028 mL in 1 JARPASTE282
58411-002-10cle de peau BEAUTE THE FOUNDATION N MO301 in 1 BOXPASTE12
58411-002-10cle de peau BEAUTE THE FOUNDATION N MO3028 mL in 1 JARPASTE282
58411-003-10cle de peau BEAUTE THE FOUNDATION N MO401 in 1 BOXPASTE12
58411-003-10cle de peau BEAUTE THE FOUNDATION N MO4028 mL in 1 JARPASTE282
58411-004-10cle de peau BEAUTE THE FOUNDATION N MO601 in 1 BOXPASTE12
58411-004-10cle de peau BEAUTE THE FOUNDATION N MO6028 mL in 1 JARPASTE282
58411-005-10cle de peau BEAUTE THE FOUNDATION N MO8028 mL in 1 JARPASTE282
58411-005-10cle de peau BEAUTE THE FOUNDATION N MO801 in 1 BOXPASTE12
58411-006-10cle de peau BEAUTE THE FOUNDATION N MO10028 mL in 1 JARPASTE282
58411-006-10cle de peau BEAUTE THE FOUNDATION N MO1001 in 1 BOXPASTE12
58411-007-10cle de peau BEAUTE THE FOUNDATION N MB1028 mL in 1 JARPASTE282
58411-007-10cle de peau BEAUTE THE FOUNDATION N MB101 in 1 BOXPASTE12
58411-008-10cle de peau BEAUTE THE FOUNDATION N MB201 in 1 BOXPASTE12
58411-008-10cle de peau BEAUTE THE FOUNDATION N MB2028 mL in 1 JARPASTE282
58411-009-10cle de peau BEAUTE THE FOUNDATION N MB301 in 1 BOXPASTE12
58411-009-10cle de peau BEAUTE THE FOUNDATION N MB3028 mL in 1 JARPASTE282
58411-010-10cle de peau BEAUTE THE FOUNDATION N MB4028 mL in 1 JARPASTE282
58411-010-10cle de peau BEAUTE THE FOUNDATION N MB401 in 1 BOXPASTE12
58411-011-10cle de peau BEAUTE THE FOUNDATION N MB5028 mL in 1 JARPASTE282
58411-011-10cle de peau BEAUTE THE FOUNDATION N MB501 in 1 BOXPASTE12
58411-012-10cle de peau BEAUTE THE FOUNDATION N MBF1028 mL in 1 JARPASTE282
58411-012-10cle de peau BEAUTE THE FOUNDATION N MBF101 in 1 BOXPASTE12
58411-997-10cle de peau BEAUTE THE FOUNDATION N MO5028 mL in 1 JARPASTE282
58411-997-10cle de peau BEAUTE THE FOUNDATION N MO501 in 1 BOXPASTE12
58411-998-10cle de peau BEAUTE THE FOUNDATION N MI1028 mL in 1 JARPASTE282
58411-998-10cle de peau BEAUTE THE FOUNDATION N MI101 in 1 BOXPASTE12
58411-999-10cle de peau BEAUTE THE FOUNDATION N MO101 in 1 BOXPASTE12
58411-999-10cle de peau BEAUTE THE FOUNDATION N MO1028 mL in 1 JARPASTE282

Products#

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

DailyMed product names page 1 of 2 · 62 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-00158411-001-10
58411-00258411-002-10
58411-00358411-003-10
58411-00458411-004-10
58411-00558411-005-10
58411-00658411-006-10
58411-00758411-007-10
58411-00858411-008-10
58411-00958411-009-10
58411-01058411-010-10
58411-01158411-011-10
58411-01258411-012-10
58411-99758411-997-10
58411-99858411-998-10
58411-99958411-999-10

Ingredients#

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

DailyMed ingredient rows page 1 of 17 · 675 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
TREHALOSEB8WCK70T7IIACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
WATER059QF0KO0RIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PISTACIA LENTISCUS (MASTIC) GUM7446H202QWIACT
GLYCINETE7660XO1CIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUPLEURUM FALCATUM ROOTX04E310LUYIACT
ZANTHOXYLUM PIPERITUM FRUIT RIND728JDI7G4MIACT
THYMUS SERPYLLUM86H4S6K51NIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
ROSA ROXBURGHII FRUITCVT1AA87FFIACT
ANGELICA ACUTILOBA ROOT3W51R3EK30IACT
PERILLA OCYMOIDES SEED OIL322MS57V7ZIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
TRISODIUM EDTA420IP921MBIACT
HYDROXYPROPYLCELLULOSE9XZ8H6N6OHIACT
PALMITIC ACID2V16EO95H1IACT
ALCOHOL3K9958V90MIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
BARIUM SULFATE25BB7EKE2EIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SILICAETJ7Z6XBU4IACT
THEANINE8021PR16QOIACT

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 THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
ndc (package): 58411-999-10
ndc (package): 58411-009-10
ndc (package): 58411-001-10
ndc (package): 58411-005-10
ndc (package): 58411-007-10
ndc (package): 58411-012-10
ndc (package): 58411-002-10
ndc (package): 58411-011-10
ndc (package): 58411-006-10
ndc (package): 58411-003-10
ndc (package): 58411-997-10
ndc (package): 58411-998-10
ndc (package): 58411-010-10
ndc (package): 58411-004-10
ndc (package): 58411-008-10
ndc (product): 58411-001
ndc (product): 58411-003
ndc (product): 58411-010
ndc (product): 58411-998
ndc (product): 58411-004
ndc (product): 58411-999
ndc (product): 58411-008
ndc (product): 58411-007
ndc (product): 58411-011
ndc (product): 58411-997
ndc (product): 58411-012
ndc (product): 58411-006
ndc (product): 58411-009
ndc (product): 58411-005
ndc (product): 58411-002
ndc11 (package): 58411000110
ndc11 (package): 58411001010
ndc11 (package): 58411099910
ndc11 (package): 58411000510
ndc11 (package): 58411000410
ndc11 (package): 58411000210
ndc11 (package): 58411099710
ndc11 (package): 58411000810
ndc11 (package): 58411000610
ndc11 (package): 58411001210
ndc11 (package): 58411000310
ndc11 (package): 58411001110
ndc11 (package): 58411000910
ndc11 (package): 58411000710
ndc11 (package): 58411099810
spl id: 4b9306fc-0dca-4458-e063-6394a90acf85
spl set id: 9507f6d1-c11c-428d-8d95-b436f27ba26a

Reported adverse events (FAERS/openFDA)#

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