FDA.reportPublic FDA data

cle de peau BEAUTE UV PROTECTIVE FOR BODY N

Product NDC
58411-956
11-digit product format
584110956
Labeler code
58411
Product ID
58411-956_4617e90c-d282-21f4-e063-6294a90a5c41
Type
HUMAN OTC DRUG
Nonproprietary name
Ensulizole, Octisalate, Octocrylene, Zinc Oxide
Dosage form
EMULSION
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-16
Substance
ENSULIZOLE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
2.384; 5.96; 5.96; 23.1248 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 FOR BODY N
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENSULIZOLE2.384 g/100mL
OCTISALATE5.96 g/100mL
OCTOCRYLENE5.96 g/100mL
ZINC OXIDE23.1248 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9YQ9DI1W42Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-956-40cle de peau BEAUTE UV PROTECTIVE FOR BODY N1 in 1 BOXEMULSION13
58411-956-40cle de peau BEAUTE UV PROTECTIVE FOR BODY N100 mL in 1 CONTAINEREMULSION1003

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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC507560fe-c7ad-329a-e063-6394a90a039a2026-04-27WarningsExact identifier
application number: M020
SoloVeganHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEYES SALES INC.435748e6-c39a-efee-e063-6294a90ad0e52026-04-27WarningsExact identifier
application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC50764f40-7881-81a3-e063-6294a90ad1cf2026-04-27WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45bd7bd-a802-33e4-e053-2a95a90a61a72026-04-23WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATEBeauty Solutions, Ltd.76e2ed34-c643-402b-9c9d-04eac789d3c22026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50ZINC OXIDEKenvue Brands LLC4fe1d3c6-7748-d966-e063-6394a90a97ff2026-04-22WarningsExact identifier
application number: M020
OVERLAPS ECTOIN MOIST SUNAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOverlaps Corp.4c3ed60b-e515-8ff0-e063-6294a90a86df2026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacestickZINC OXIDESunny Day Creations50101b55-793e-dbe4-e063-6394a90a61992026-04-22WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%S&C Hampton Sun LLCe6103de6-1d80-46fd-b9d4-893f60941def2026-04-22WarningsExact identifier
application number: M020
PhotoAge GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMACROMOTION, INC.50164bd8-469d-9ec1-e063-6294a90a543d2026-04-22WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun StickAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD49947114-5137-dc45-e063-6394a90ad9d02026-04-22WarningsExact identifier
application number: M020
Sky and Sol Intense Healing Lip JellyNON-NANO ZINC OXIDEDelta Ecommerce LLC2ddaa215-7433-c8fa-e063-6394a90a43162026-04-22WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
application number: M020
BLDG Active Skin Repair Face and Body Performance SunscreenZINC OXIDEInnovacyn, Inc.70cb98cf-739b-4d46-b45a-535ff0a4531c2026-04-21WarningsExact identifier
application number: M020
Freaks of Nature Mineral SunscreenZINC OXIDE MINERAL SUNSCREENEmpack Spraytech Inc.4ffdb1c6-b2c6-628f-e063-6394a90a27692026-04-21WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Water Sun CreamAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD5004126b-0a9c-21fb-e063-6294a90a52372026-04-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-956-40584110956401 CONTAINER in 1 BOX (58411-956-40) / 100 mL in 1 CONTAINER1 container2025-12-16NoNoCurrent