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 166 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8acb660f-94bd-4c4f-b0c1-3682cf8ed5432025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.fad2bec7-c5f4-45f4-aff4-a5022033cb6a2025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.39856c69-84fb-4b12-a713-8912263e42b12025-11-07WarningsExact identifier
application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Cream FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.287aa255-4601-c5be-e063-6394a90a4d742025-11-07WarningsExact identifier
application number: M020
e l f Holy Hydration Face SPF 30 Sunscreen,AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc44a8028b-731d-4561-b2e3-ee9738ad8d302025-11-07WarningsExact identifier
application number: M020
e l f Sun Boss Gloss SPF 25 Sunscreen Its your MauveZINC OXIDEe.l.f. Cosmetics, Inc.bce21361-c92c-40ad-a373-db3b83b15b8a2025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer SunburstAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc49d912c7-259a-487d-a523-b14031bfaab62025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer SunlightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d2025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer SunbeamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.f818f524-0263-4f89-b4f3-4dd83d688e7e2025-11-07WarningsExact identifier
application number: M020
e.l.f Invisible Sunscreen SPF 35AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Incc2af5591-04df-4958-901e-dbe11698b8442025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush MuchZINC OXIDEe.l.f. Cosmetics, Inc.53d64042-f9ef-494d-a347-490c6a3c49b82025-11-07WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f cosmetics,Inc.547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d2025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my JamZINC OXIDEe.l.f. Cosmetics, Inc.b7d56015-4734-4ce4-b40d-64236df810e32025-11-07WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Peachy KweenZINC OXIDEe.l.f. Cosmetics, Inc.4d9784b6-c54d-483d-a5ba-c557a05300ec2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOWZINC OXIDEIn The Pynk LLC13badac4-e310-9589-e063-6394a90ab06b2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOURZINC OXIDEIn The Pynk LLC13bb8426-27cd-fbc9-e063-6294a90a8bf82025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOUZINC OXIDEIn The Pynk LLC1365c6d8-64cb-3cb3-e063-6394a90a9d642025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 10wZINC OXIDEe.l.f. Cosmetics, Incc8a935e6-f7ac-4e3a-e053-2a95a90a877a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 11wZINC OXIDEe.l.f. Cosmetics, Incc8a94fb4-8752-587c-e053-2995a90a1e9a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 13wZINC OXIDEe.l.f. Cosmetics, Incc8a9bf6c-80cd-5884-e053-2a95a90a4a662025-11-07WarningsExact 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