FDA.reportPublic FDA data

cle de peau BEAUTE PROTECTIVE LIP TREATMENT

Product NDC
58411-856
11-digit product format
584110856
Labeler code
58411
Product ID
58411-856_47a7a718-ae9f-4001-e063-6294a90a8857
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, and OCTOCRYLENE
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-01
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
100; 196; 120 mg/4g; mg/4g; mg/4g
NDC exclude flag
No
Listing certified through
2027-12-31
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 PROTECTIVE LIP TREATMENT
Brand name suffix
SPF 25
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE100 mg/4g
OCTINOXATE196 mg/4g
OCTOCRYLENE120 mg/4g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal 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
addd9885-362c-4ce0-9a6e-759e71d8756cAvailable 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
58411-856-10cle de peau BEAUTE PROTECTIVE LIP TREATMENTSPF 254 g in 1 BOTTLE, GLASSEMULSION43
58411-856-20cle de peau BEAUTE PROTECTIVE LIP TREATMENTSPF 251 in 1 BOXEMULSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-856CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT SPF 25 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) EMULSION [SHISEIDO AMERICAS CORPORATION]2Current NDC, 2 package rows20241225_addd9885-362c-4ce0-9a6e-759e71d8756c.zip

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 150 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Srubs SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEITW Pro Brands06c1dc42-5a01-f898-e063-6394a90a1a1a2025-12-05WarningsExact identifier
application number: M020
OUHOE Tinted SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4540f542-248d-bcf5-e063-6294a90aabca2025-12-05WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS45c7703b-7ab4-2ef2-e063-6294a90a2b462025-12-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4645b051-ef5a-521e-e063-6294a90a24042025-12-05WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen bkidsZINC OXIDEKAS Direct LLC dba BabyGanicsf717cd89-194b-42e3-a079-24b2903deb292025-12-05WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 sunscreen shimmer sunscreen mist for the faceHOMOSALATE , OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b662a-70ed-8ec5-e063-6294a90a005b2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick sunlightHOMOSALATE ,OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b71a9-2240-853f-e063-6394a90ac8f42025-12-04WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 SCENTED gel sunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,OCTIONXATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d1-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick solarHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d3-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Silk Body Cream SUNGLOW 05 FRAGRANCE Sunscreen SPF 30 body creamHOMOSALATE, OCTOCRYENE, OCTISALATE, QCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b86fa-6c1c-a708-e063-6394a90a47a92025-12-04WarningsExact identifier
application number: M020
Poolside Clear Intentions Invisible Face Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b902d-892d-15f1-e063-6294a90a30242025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba227-7973-1378-e063-6294a90ae8932025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba704-6fbd-d5a0-e063-6394a90a2fbc2025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic TwistHOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb62e-b603-7663-e063-6294a90a46db2025-12-04WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 ROSEDUSTLIP 30 CLEARThe Center Brands, LLC33d5e1ad-ba7a-25f8-e063-6294a90aa38e2025-12-04WarningsExact identifier
application number: M020
Resting Beach Face SPF30 Anti-Pollution Sunscreen SerumBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENEEveryday Group Limted54f8aca8-fbbc-498a-aaf8-aee716511dde2025-12-04WarningsExact identifier
application number: M020
Oh My Bod SPF50 Antioxidant Infused Dry Touch SunscreenBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEEveryday Group Limted48e70326-ecf7-44c9-a4cc-2044bd6a64152025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM TINTEDZINC OXIDEReve Skincare LLC35f5652f-3e6b-71c9-e063-6294a90a9e862025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM IVORTYZINC OXIDEReve Skincare LLC35f4dd1b-c3d9-8408-e063-6394a90a79142025-12-04WarningsExact identifier
application number: M020
Activated Mineral Sunscreen TintedACTIVATED MINERAL SUNSCREEN TINTEDReve Skincare LLC312a32a7-d253-f10c-e063-6294a90a803a2025-12-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-856-10584110856104 g in 1 BOTTLE, GLASS4 gHistorical
58411-856-20584110856201 BOTTLE, GLASS in 1 BOX (58411-856-20) / 4 g in 1 BOTTLE, GLASS (58411-856-10) 2022-08-01NoNoCurrent