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 173 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
application number: M020
SEKKISEI HERBAL UV DEFENSE gelAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKOS America, Inc.cb0faa3a-68f8-49c5-8c28-3338b1b27cd82025-10-31WarningsExact identifier
application number: M020
Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2c749a52-adaa-2609-e063-6294a90a8fc22025-10-30WarningsExact identifier
application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4260e410-d2d5-71b4-e063-6294a90a05b82025-10-30WarningsExact identifier
application number: M020
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
application number: M020
WEIGHTLESS PROTECTION SPF 30OCTINOXATE, ZINC OXIDE, OCTISALATEBotanical Science Technologiesde9a97b8-6633-4d71-e053-2995a90a5e8f2025-10-30WarningsExact identifier
application number: M020
Avinichi Noni Sol Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.9e534e32-efea-4dcf-adc1-18de3847ac042025-10-30WarningsExact identifier
application number: M020
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
application number: M020
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDETHG Beauty USA LLC1cd10158-c346-60c9-e063-6294a90a54bd2025-10-29WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.0fb5a140-838d-3226-e063-6294a90a88602025-10-29WarningsExact identifier
application number: M020
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
application number: M020
Hello Bello Kids Mineral SunscreenZINC OXIDE TITANIUM OXIDEHello Bello3e7a3e8e-eacf-0a30-e063-6294a90ab7ec2025-10-29WarningsExact identifier
application number: M020
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.0fb58346-a638-3091-e063-6394a90ad7542025-10-28WarningsExact identifier
application number: M020
TIBENA EVERYTHING MULTI CUSHION SPF50HOMOSALATE, TITANIUM DIOXIDEKONAD CO LTD421eda8f-62b2-30fb-e063-6394a90a49472025-10-27WarningsExact identifier
application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Drops Face SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.289efa6d-427b-8be6-e063-6394a90adae32025-10-27WarningsExact identifier
application number: M020
goPure SunscreenZINC OXIDENatural Lifestyle Brands, LLC dba GoPure beautya74ec20b-8436-4030-820c-01fd88134f402025-10-27WarningsExact 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