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 297 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANYZINC OXIDERms organics LLC1a1aebea-ed0c-ac92-e063-6294a90aeae62024-06-04WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc OnlyZINC OXIDESPF Ventures, LLC1a1bf910-f1bc-bd75-e063-6294a90a663f2024-06-04WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
application number: M020
EltaMD UV Sport SPF50ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREENCP Skin Health Group, Inc.dffc3fde-5b6e-4a62-8289-9733be43455b2024-05-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.aef8388f-84bb-4e2b-8ae2-aa64f415a6322024-05-28WarningsExact identifier
application number: M020
SPF50 Sunscreen CariposaZINC OXIDETalent Brands Company LLC1938fa13-875a-140e-e063-6294a90a55142024-05-24WarningsExact identifier
application number: M020
Derma E Vitamin C Weightless Moisturizer SPF 45ZINC OXIDEderma ea3b404a6-e4b1-4c08-a8ef-77446dd2e4112024-05-24WarningsExact identifier
application number: M020
COOLA Classic Liplux Lip Balm SPF 30 OriginalAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeeb420f0-c92f-0d96-e053-2a95a90afe362024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Nude BeachTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee2842c3-65e0-3904-e053-2a95a90aabff2024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 FirecrackerTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee026a1c-885b-256f-e053-2a95a90af5642024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 50 Mineral Sunscreen Vanilla CocoTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCec96dee8-85e8-3147-e053-2995a90aaf532024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze GoddessTITANIUM DIOXIDECOOLA, LLCeeb406c6-a543-379a-e053-2995a90a49982024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh RoseTITANIUM DIOXIDECOOLA, LLCee01642f-478e-b307-e053-2a95a90a7d812024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Coco MangoZINC OXIDECOOLA, LLCeca9ae89-19dc-516d-e053-2995a90a46982024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Untinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCecabcc89-fb09-41a9-e053-2995a90a8b312024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Tinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee018c21-dca7-28aa-e053-2a95a90a3bdb2024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Citrus CoolerZINC OXIDECOOLA, LLCecaad342-1873-60bc-e053-2995a90a59522024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Golden DazeTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeeb70034-0f8d-a46d-e053-2a95a90a81302024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Diamond DustTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeec83ecb-d0ab-7857-e053-2995a90a40ed2024-05-22WarningsExact 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