FDA.reportPublic FDA data

cle de peau BEAUTE RADIANT FOUNDATION N M

Product NDC
58411-976
11-digit product format
584110976
Labeler code
58411
Product ID
58411-976_4ba8f2ec-8b92-1b13-e063-6394a90a9e57
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-02
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
1.06; .29 g/21mL; g/21mL
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 RADIANT FOUNDATION N M
Brand name suffix
O30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1.06 g/21mL
TITANIUM DIOXIDE.29 g/21mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3be1fe06-bd3b-4078-bee9-d3caf8d068ffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-976-60cle de peau BEAUTE RADIANT FOUNDATION N MO301 in 1 BOXCREAM12
58411-976-60cle de peau BEAUTE RADIANT FOUNDATION N MO3021 mL in 1 TUBECREAM212

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 273 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bali Body Cacao Tanning Oil SPF 15OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd03c0b83d-0d85-9e69-e063-6394a90a61422024-10-21WarningsExact identifier
application number: M020
ALDI LACURA KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCe34f37d7-02a5-0b72-e053-2a95a90acf832024-10-21WarningsExact identifier
application number: M020
Aldi Lacura Ultra Light Body SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7ac082c-def8-4379-e053-6294a90a57e32024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 30 Broad Spectrum SPF 30 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7bdc1f7-d961-4596-e053-6394a90a1d872024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Ultra Light Dry-Touch 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7b2cf4e-468c-3406-e053-6394a90a21392024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 50 Broad Spectrum SPF 50 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7b32aa8-2e56-3725-e053-6294a90a18d22024-10-21WarningsExact identifier
application number: M020
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50ZINC OXIDEBliss Products Holdings LLCf262e5a7-3c57-a6d8-e053-2995a90aacbc2024-10-21WarningsExact identifier
application number: M020
Berkley Jensen Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBJWCfbd65277-7aff-de19-e053-6394a90a94962024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC01bfe44c-655f-404c-981e-8d5f6728a7382024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLCaa612570-b70a-4910-8086-6634834beb702024-10-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf5bd673a-46e5-43d5-9d76-8ddc5da701462024-10-21WarningsExact identifier
application number: M020
Sun Bum Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLC6fcec9f9-bee0-4884-8c72-be273426f9162024-10-21WarningsExact identifier
application number: M020
sunscreenSKIN BARRIER SUN SHIELD SPF 30True Botanicals, Inc.d70eea23-7715-c17b-e053-2a95a90a839f2024-10-18WarningsExact identifier
application number: M020
First Aid Only SunX30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcme United Corporation24c22903-8911-81d9-e063-6394a90a108b2024-10-18WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD33f8760c-2953-44a6-9239-424fdb97a5b32024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c85e5094-d442-55a9-e053-2995a90aed122024-10-18WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.24c78897-3136-f24b-e063-6394a90aa80a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f451c472-1d9f-1fbc-e053-2995a90a114e2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenZINC OXIDEFruit Of The Earth, Inc.f4490608-6cce-90f3-e053-2995a90a49302024-10-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-976-60584110976601 TUBE in 1 BOX (58411-976-60) / 21 mL in 1 TUBE1 tube2024-12-02NoNoCurrent