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
Ingredient	Strength
AVOBENZONE	100 mg/4g
OCTINOXATE	196 mg/4g
OCTOCRYLENE	120 mg/4g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
addd9885-362c-4ce0-9a6e-759e71d8756c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58411-856-10	cle de peau BEAUTE PROTECTIVE LIP TREATMENTSPF 25	4 g in 1 BOTTLE, GLASS	EMULSION	4		3
58411-856-20	cle de peau BEAUTE PROTECTIVE LIP TREATMENTSPF 25	1 in 1 BOX	EMULSION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58411-856	CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT SPF 25 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) EMULSION [SHISEIDO AMERICAS CORPORATION]	2	Current NDC, 2 package rows	20241225_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 79 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	58efeaaf-d3c6-44e9-b60f-8f22f5bb1d33	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f6b4a90b-5905-4f62-9e35-f2b1dda8dddd	2026-01-16	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	42c8fd50-73c6-480b-9d7e-31157e586929	2026-01-16	Warnings	Exact identifier application number: M020
HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30	ZINC OXIDE	KENDO HOLDINGS INC.	18fb7472-746f-339a-e063-6294a90a267d	2026-01-16	Warnings	Exact identifier application number: M020
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50	ZINC OXIDE	Noble Panacea Labs, Inc.	aed57f81-4b7d-42dc-993e-6bb10f93b02a	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	0d9f132c-7630-4261-a0f8-fc7a4377731f	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	f292da7d-ffd2-41c3-9a64-619aab19ff18	2026-01-15	Warnings	Exact identifier application number: M020
Multivit Sun Protector	TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	abdb560d-29be-41dc-ad23-54ea571acb14	2026-01-15	Warnings	Exact identifier application number: M020
BeautyBarrier	ZINC OXIDE	NAKED SUNDAYS PTY LTD	45740afa-230d-4dd5-e063-6394a90a102f	2026-01-15	Warnings	Exact identifier application number: M020
Glow This Way	OCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATE	Koco Life LLC	4619cf96-987a-3e88-e063-6294a90afbe9	2026-01-15	Warnings	Exact identifier application number: M020
Reef safe lip balm 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	486930f2-026b-14b4-e063-6394a90aa031	2026-01-15	Warnings	Exact identifier application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	CLINIQUE LABORATORIES LLC	316bf6f8-7d30-2560-e063-6294a90afb8a	2026-01-15	Warnings	Exact identifier application number: M020
Wellcare Sunstick Lip Balm	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE	BAMKO, LLC	ef977575-7ef0-fc09-e053-2a95a90a8993	2026-01-15	Warnings	Exact identifier application number: M020
Bali Body Sheer Glow Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	4872793c-a7c0-1b65-e063-6394a90a8b3a	2026-01-15	Warnings	Exact identifier application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Volition Beauty	2631de4b-66e3-0547-e063-6394a90a822c	2026-01-15	Warnings	Exact identifier application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30	ZINC OXIDE	SKINN COSMETICS, LLC	350ed168-ab3b-f314-e063-6394a90a8bbf	2026-01-15	Warnings	Exact identifier application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	StriVectin Operating Company, Inc.	4873a262-a19b-555e-e063-6394a90a182a	2026-01-15	Warnings	Exact identifier application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	e843bb6b-257f-4425-95bc-41774e032a09	2026-01-15	Warnings	Exact identifier application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	1e18f1dd-a4e4-455a-9699-5634b9559678	2026-01-15	Warnings	Exact identifier application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	485c345f-0928-fa1a-e063-6294a90aa856	2026-01-14	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58411-856-10	58411085610	4 g in 1 BOTTLE, GLASS	4 g				Historical
58411-856-20	58411085620	1 BOTTLE, GLASS in 1 BOX (58411-856-20) / 4 g in 1 BOTTLE, GLASS (58411-856-10)		2022-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clé de peau BEAUTÉ PROTECTIVE LIP TREATMENT SPF 25	SHISEIDO AMERICAS CORPORATION	2026-01-05	HUMAN OTC DRUG LABEL	3