La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen

Product NDC: 69625-583
11-digit product format: 696250583
Labeler code: 69625
Product ID: 69625-583_ac7275a0-234a-4918-befd-5e2a0d6c1133
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: Cosmetique Active Production
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-12-21
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69625-583	69625-583-01	D	Discontinued by firm		2026-10-16
excluded package	package	69625-583	69625-583-05	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	30 mg/mL
HOMOSALATE	50 mg/mL
OCTISALATE	50 mg/mL
OCTOCRYLENE	70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	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
f9645435-e138-45df-a5ec-6dc7b3ff792d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69625-583-01	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	75 mL in 1 BOTTLE	LOTION	75	3
69625-583-01	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	1 in 1 CARTON	LOTION	1	3
69625-583-02	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	2 mL in 1 PACKET	LOTION	2	3
69625-583-03	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	3 mL in 1 TUBE	LOTION	3	3
69625-583-04	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	100 mL in 1 TUBE	LOTION	100	3
69625-583-04	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	1 in 1 CARTON	LOTION	1	3
69625-583-05	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	1 in 1 CARTON	LOTION	1	3
69625-583-05	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	75 mL in 1 TUBE	LOTION	75	3
69625-583-06	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	1 in 1 CARTON	LOTION	1	3
69625-583-06	La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	40 mL in 1 TUBE	LOTION	40	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69625-583	LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [COSMETIQUE ACTIVE PRODUCTION]	3	Current NDC, 10 package rows	20240410_f9645435-e138-45df-a5ec-6dc7b3ff792d.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 54 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	4ce63abb-e716-40de-e063-6394a90a6e76	2026-03-15	Warnings	Exact identifier application number: M020
GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CLIO COSMETICS Co., Ltd.	8d147089-709f-4468-a47d-9251e737c9a4	2026-03-15	Warnings	Exact identifier application number: M020
Cay Skin Isle Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Cay Skin, Inc.	d92a17c4-9827-5fb1-e053-2a95a90a9ca1	2026-03-13	Warnings	Exact identifier application number: M020
DAILY FACE SUNSCREEN Broad Spectrum SPF 30	ZINC OXIDE	Lilyana Naturals LLC	e5f53e2f-6566-4eac-b9b5-7697abaf044b	2026-03-13	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	af052521-bfa6-4142-a10b-ef51f474a077	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	42647444-93a3-4d2c-9bfc-91621fd098f7	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Babies SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	a4b9d7c0-dc09-4f0e-8b65-90ba180552bf	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
TINTED WATERY SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	KSISTERS PTE. LTD.	4ced53d0-8bfc-ff8e-e063-6294a90a9dbd	2026-03-13	Warnings	Exact identifier application number: M020
Round Lab Birch Juice Mother s Day Gift Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4cf03092-7886-ffa1-e063-6294a90a2aad	2026-03-13	Warnings	Exact identifier application number: M020
Daily Moisturizing Mineral Sunscreen	BROAD SPECTRUM SPF30	EDINA PLASTIC SURGERY,LTD.	4d056e2b-5813-da42-e063-6294a90ac519	2026-03-13	Warnings	Exact identifier application number: M020
La Roche Posay Anthelios Sunscreen SPF 60 Ultra light	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	L'Oreal USA, Inc.	dad00eee-92cd-7610-e053-2a95a90a1fac	2026-03-13	Warnings	Exact identifier application number: M020
VITARAN REJUVENA SUNCARE	ALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATE	BR PHARM CO. , Ltd.	4cb7af72-49f6-0738-e063-6394a90a79eb	2026-03-12	Warnings	Exact identifier application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 21	ZINC OXIDE, OCTISALATE, OCTOCRYLENE	PFD Co.,Ltd.	4cd0a8a7-11aa-e168-e063-6394a90a2ff2	2026-03-12	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Vi-Jon, LLC	3da4706e-7c1a-435e-9603-e9aa98432018	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Nice-Pak Products, LLC	53806657-7b4d-45ff-a75b-9340dcd8140e	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Nice-Pak Products, LLC	08237b4c-4e5c-4b12-9510-2f8d64ab7f3a	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 Fairfax	ZINC OXIDE	Tower 28	108851ac-3812-4c02-a04a-9f9a7f529ed6	2026-03-12	Warnings	Exact identifier application number: M020
DIY Booster SPF 30 Facial Serum Unscented	OCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDE	Andalou naturals	ebaf5ef7-84aa-4cb1-a701-2e0d0fd357df	2026-03-12	Warnings	Exact identifier application number: M020
Vacation SPF 50 Classic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation INC.	f268fb1c-d7c2-f2f9-e053-2995a90a9e22	2026-03-12	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440C	TITANIUM DIOXIDE	Kenvue Brands LLC	4c335d9c-40ca-c0ce-e063-6394a90ac20a	2026-03-11	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
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
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
69625-583-01	69625058301	75 mL in 1 BOTTLE	75 ml				Historical
69625-583-02	69625058302	2 mL in 1 PACKET (69625-583-02)	2 ml	2016-12-21	No	No	Current
69625-583-03	69625058303	3 mL in 1 TUBE (69625-583-03)	3 ml	2016-12-21	No	No	Current
69625-583-04	69625058304	1 TUBE in 1 CARTON (69625-583-04) / 100 mL in 1 TUBE	1 tube	2022-12-12	No	No	Current
69625-583-05	69625058305	1 in 1 CARTON					Historical
69625-583-06	69625058306	1 TUBE in 1 CARTON (69625-583-06) / 40 mL in 1 TUBE	1 tube	2024-01-01	No	No	Current