FDA.reportPublic FDA data

cle de peau BEAUTE UV PROTECTIVE N

Product NDC
58411-955
11-digit product format
584110955
Labeler code
58411
Product ID
58411-955_4617e324-8d48-1ba3-e063-6294a90ac84f
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-16
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.7825; 7.75; 3.875; 3.875 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
cle de peau BEAUTE UV PROTECTIVE N
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.7825 g/50mL
HOMOSALATE7.75 g/50mL
OCTISALATE3.875 g/50mL
OCTOCRYLENE3.875 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18ed9b7f-bdbe-45d7-a38c-6d065080ae99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-955-60cle de peau BEAUTE UV PROTECTIVE N1 in 1 BOXCREAM12
58411-955-60cle de peau BEAUTE UV PROTECTIVE N50 mL in 1 TUBECREAM502

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 323 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
application number: M020
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
application number: M020
DERMAKA Broad Spectrum SPF-42 Sunscreen UntintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9aa24e1f-e338-4947-a437-554fb6b227a22023-11-11WarningsExact identifier
application number: M020
TIGER BABY Baby Sunscreen SPF-50ZINC OXIDEBRICKELL BRANDS LLCf2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c2023-11-11WarningsExact identifier
application number: M020
Brickell Mens Products Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLCa61e20e4-d5c9-4dc4-a18a-cc88b358d15c2023-11-11WarningsExact identifier
application number: M020
EIGHT SAINTS Chase The Sun SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c2023-11-11WarningsExact identifier
application number: M020
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30ZINC OXIDESALES BRAIN HOLDINGS LLCec06bc4b-90d6-4b41-9086-f57737a34d912023-11-11WarningsExact identifier
application number: M020
TRENDY JOHN SPF-32 Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETRENDY JOHN LLC80dccecb-fbb3-4af6-9cb4-6acea733e9962023-11-11WarningsExact identifier
application number: M020
CARIBBEAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC19117321-c37b-4b37-9bd6-7c5c973e2f312023-11-11WarningsExact identifier
application number: M020
MIAMI BEACH BUM Blocked SPF-30 SunscreenZINC OXIDEMIAMI BEACH BUM669443a1-7b54-454f-b22f-8cfa9df38bbb2023-11-11WarningsExact identifier
application number: M020
STRYX Daily Moisturizer SPF-30OCTISALATE, ENSULIZOLESTRYX MEN, INC.2bac4348-5b5d-41cc-893e-b9d5c1215ab02023-11-11WarningsExact identifier
application number: M020
SIMPLI DAY All In One SmartCream SPF 42ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLESIMPLI SKIN MD LLCe5aab0ec-eda2-4073-998a-966202dc22332023-11-11WarningsExact identifier
application number: M020
HAWAIIAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC3c43fe36-2c24-4859-a262-8af4d3420e472023-11-11WarningsExact identifier
application number: M020
JOYSPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC3ca50033-5bcb-4a6d-8aba-a797c5b8d0e92023-11-11WarningsExact identifier
application number: M020
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETANCEUTICALS, LLC8640b971-7c99-4c8f-ac5c-ecdd88b99fe02023-11-11WarningsExact identifier
application number: M020
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.806b4e40-0e02-424b-80e7-026a211b4dfe2023-11-11WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for WomenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INC0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed2023-11-11WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPF 50ZINC OXIDEProven Skincarebb921e91-9faf-4210-9091-ab511af9012a2023-11-10WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPFZINC OXIDEProven Skincaref4d682bc-825f-494c-8528-3d328dc639942023-11-10WarningsExact identifier
application number: M020
Ultra Replenishing Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMCosMedical Technologies, LLC92ad5d7a-9adb-7d55-e053-2995a90a80e72023-11-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-955-60584110955601 TUBE in 1 BOX (58411-955-60) / 50 mL in 1 TUBE1 tube2025-12-16NoNoCurrent