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		2026-10-20
excluded package	package	69625-583	69625-583-05	D	Discontinued by firm		2026-10-20

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 70 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	7fe05ef6-dd5f-4f25-bbf7-24f939642707	2026-01-23	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Nacre	CEILE SPF 30 PRIME PROTECT RADIATE NACRE	LE COSMETICS INC	4915de09-3a2c-cb75-e063-6394a90a6a57	2026-01-23	Warnings	Exact identifier application number: M020
SPF 50 Sunscreen Stick	ZINC OXIDE	Australian Gold	248d761c-2120-4019-9463-9952bc367e73	2026-01-23	Warnings	Exact identifier application number: M020
SOLBAR THIRTY	SUNSCREEN	Person and Covey	48ed3be8-d146-ec2c-e063-6394a90a6c4d	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA ALL AROUND ESSENCE SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Able C&C Co., Ltd.	48f557b5-a844-8c94-e063-6394a90af220	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Able C&C Co., Ltd.	48f5e9ab-38e0-f12c-e063-6294a90aab8b	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	48f6361d-d738-62df-e063-6294a90aaac5	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 35 AVO	SUNSCREEN	Person and Covey	4a5692d5-0835-d18f-e063-6394a90a2929	2026-01-22	Warnings	Exact identifier application number: M020
Sunscreen Lip Balm SPF15	OCTINOXATE, AVOBENZONE, OCTISALATE	Dongguan Taimeng Accessories Co., Ltd.	48f70710-7960-5fa5-e063-6394a90a4ce6	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 40 ZINC	SUNSCREEN	Person and Covey	48fc01dd-0be4-5c63-e063-6294a90a2362	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 40 SHIELD	SUNSCREEN	Person and Covey	48fcd463-8ce4-1e78-e063-6394a90a98e7	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 50 FIFTY	SUNSCREEN	Person and Covey	48fef521-1b24-d0d5-e063-6394a90ac7b1	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	7456f4bb-d0ec-439d-b807-d00b4c01c111	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	2dd51960-515f-4502-b261-5e5d5f57e091	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5b835716-af13-4e23-bdae-d391864acb6f	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	fa258570-ee21-423d-bad6-010d14792a86	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	fa84c1b5-a9b6-408e-b9fd-0dadebaf374e	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	6b7a016c-c3b1-4f90-80c9-fe47c5291649	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5d029d93-7f3d-4624-bcd7-40df9230414e	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	8f724d68-3c6e-4b95-894e-78b2da220a30	2026-01-22	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