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 224 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC2d2c58e2-0d15-4383-adae-12fc17b8ea502025-03-20WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC1907126c-fd95-86e8-e063-6394a90a23ca2025-03-20WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLC4504a10d-6130-4ec5-823a-ab970709e6d72025-03-20WarningsExact identifier
application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEEai-jr 286, Inc30caf1dd-142d-85d3-e063-6394a90a0c882025-03-20WarningsExact identifier
application number: M020
Sun Shades Lip Balm Cranberry TangerineAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.f39606be-19c8-58d1-e053-2a95a90a908f2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCaa937596-2378-469f-a0e1-9700044e83b32025-03-20WarningsExact identifier
application number: M020
Obagi Medical Way to Glow KitHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCf6f6e219-4ef6-be3b-e053-6294a90a660d2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCe8d19915-8996-42df-a47b-2ce00d2bbe682025-03-20WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION21bde283-a554-45c8-8733-2a8adeff41b12025-03-20WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION7a98171f-bf21-40d4-bc78-883aa0b0c4382025-03-20WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.5e2d7c94-d70a-47e4-9a4b-5953fe38ede22025-03-19WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.50206f9e-2dd5-494f-9eed-f7d7ea6efda92025-03-18WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDEThe Creme Shop30a4280b-4a9f-4c18-e063-6394a90a85e62025-03-18WarningsExact identifier
application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45ZINC OXIDEEai-jr 286, Inc30a5ec14-63d7-e678-e063-6294a90abb572025-03-18WarningsExact identifier
application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEExtra Shade, LLCd197dfe3-c754-4a3d-9edd-335f3fce105c2025-03-18WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc88e44da-0b0e-4744-8b4b-4d9d418f29d72025-03-18WarningsExact identifier
application number: M020
MDP UV BIO SUNSCREENZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATESKINIDEA CO., LTD3087771e-2ab8-2198-e063-6294a90a37d42025-03-17WarningsExact identifier
application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.2b38da59-b83e-4285-e063-6294a90ac6a72025-03-17WarningsExact identifier
application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREENHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC263ef8e8-e0c4-42e6-bb26-7581a437b35a2025-03-14WarningsExact identifier
application number: M020
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact 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