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		2026-10-21
excluded package	package	69625-583	69625-583-05	D	Discontinued by firm		2026-10-21

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 95 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eucerin Oil-Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cda04484-ba84-2276-e053-2a95a90a41c8	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	240dd76a-8f39-caec-e063-6294a90abbbc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan SPF 30	AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3994886-2ebe-a9d2-e053-2995a90aaf9a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3d471b8-7430-98b0-e053-2995a90aba4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	241f78be-0d7f-c5ca-e063-6294a90a997a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan Sunscreen SPF 45	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdort Inc	d39a009d-1f33-88bb-e053-2a95a90a03a0	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d460d669-42df-46c0-e053-2a95a90ad77b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 8	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	d370094c-3373-594b-e053-2a95a90a114a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	0a5a35be-9e24-18dd-e063-6394a90a097f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d462081f-f082-5df2-e053-2995a90aa1d9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3e66496-bc3c-d189-e053-2a95a90a06b6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc.	c05388dc-4282-ee79-e053-2a95a90a376a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	b60dcbd1-42d0-646f-e053-2a95a90a497d	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d474fea9-65a7-672b-e053-2a95a90ab989	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 40	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	d4d9ad73-6394-2391-e053-2a95a90a2df6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	df498e82-e1c9-51eb-e053-2a95a90a49b6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	d3984138-763b-1002-e053-2995a90acefc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	d8b0d5ad-a82c-5304-e053-2a95a90afa63	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	d8d80a15-8282-a18e-e053-2a95a90a2c6c	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d915cb28-2813-5a38-e053-2a95a90a45c6	2025-12-31	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