CERAMIDE PREMIERE BROAD SPECTRUM SPF 30

Product NDC: 10967-669
11-digit product format: 109670669
Labeler code: 10967
Product ID: 10967-669_471d8a24-eac2-ccb8-e063-6294a90aa3ec
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octisalate, Oxybenzone, Octocrylene, Avobenzone
Dosage form: EMULSION
Route: TOPICAL
Labeler: REVLON
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-02-06
Substance: OXYBENZONE; OCTINOXATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength: 4; 7.5; 3; 2; 5 mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10967-669-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10967-669-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10967-669-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10967-669-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10967-669-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10967-669-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10967-669-17	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10967-669-17	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10967-669-17	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10967-669-17	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10967-669-17	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10967-669-17	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10967-669-17	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10967-669-17	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10967-669-17	`1332a3947898…`	`d4bfe170f9cd…`

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: CERAMIDE PREMIERE BROAD SPECTRUM SPF 30
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBENZONE	4 mg/g
OCTINOXATE	7.5 mg/g
OCTOCRYLENE	3 mg/g
AVOBENZONE	2 mg/g
OCTISALATE	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
95OOS7VE0Y	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
4X49Y0596W	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
b3358bfd-7fe5-33e2-e053-2a95a90ac2ea	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-12-29	CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30
2023-07-28	CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30
2022-02-09	CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30
2022-01-28	CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10967-669-17	CERAMIDE PREMIERE BROAD SPECTRUM SPF 30	49 g in 1 JAR	EMULSION	49		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10967-669	CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) EMULSION [REVLON]	2	Current NDC, Legacy NDC, 1 package rows	20220210_b3358bfd-7fe5-33e2-e053-2a95a90ac2ea.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 138 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHADED	TITANIUM DIOXIDE, ZINC OXIDE	Potency No. 710 LLC	31177bbd-68b0-8b24-e063-6294a90aa8d8	2025-12-10	Warnings	Exact identifier application number: M020
SHADED	TITANIUM DIOXIDE, ZINC OXIDE	Potency No. 710 LLC	3117e138-83a1-0931-e063-6394a90abe43	2025-12-10	Warnings	Exact identifier application number: M020
SHADED	TITANIUM DIOXIDE, ZINC OXIDE	Potency No. 710 LLC	31188175-a4ca-449f-e063-6394a90a3c05	2025-12-10	Warnings	Exact identifier application number: M020
COVERED	ZINC OXIDE	Potency No. 710 LLC	3118c3ed-f0f0-f997-e063-6294a90a53a9	2025-12-10	Warnings	Exact identifier application number: M020
COVERED	ZINC OXIDE	Potency No. 710 LLC	3117faeb-1792-1b2e-e063-6294a90a92df	2025-12-10	Warnings	Exact identifier application number: M020
Non-Tinted Mineral Foaming Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Restore Skin Therapy, LLC	364b6af2-a0ed-4a17-e063-6394a90a3a17	2025-12-10		Exact identifier application number: M020
Morning Replenish	ZINC OXIDE	Restore Skin Therapy, LLC	364b26c2-a1bb-9660-e063-6294a90a14d1	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Tinted	ZINC OXIDE	Fleur de Lune, LLC	34288989-35b8-3aa3-e063-6394a90ac2c4	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Tinted	ZINC OXIDE	Fleur de Lune, LLC	3418394b-fede-65ce-e063-6394a90ad5f9	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Non-Tinted	ZINC OXIDE	Fleur de Lune, LLC	341871e5-c170-7560-e063-6394a90a8eee	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Non-Tinted	ZINC OXIDE	Fleur de Lune, LLC	3428bdbb-1f18-a29b-e063-6294a90addbc	2025-12-10		Exact identifier application number: M020
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b2403-4f4a-3e77-e063-6294a90a4f0a	2025-12-10		Exact identifier application number: M020
Sheer Mineral Sunscreen Bar	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b69d5-f0e1-99cd-e063-6294a90abb6e	2025-12-10		Exact identifier application number: M020
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342c3f42-c17f-f777-e063-6394a90a8058	2025-12-10		Exact identifier application number: M020
Lip SPF	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396d3fdd-99d8-77e8-e063-6294a90aec2f	2025-12-10		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396cae82-7641-e1b2-e063-6394a90a7c07	2025-12-10		Exact identifier application number: M020
Solar Knight SPF 40 Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	MASCARENAS ENTERPRISES, INC.	36c27c91-22ac-205c-e063-6294a90ab379	2025-12-10		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396ce15a-06ad-4055-e063-6294a90a27fb	2025-12-10		Exact identifier application number: M020
Dermablue Daily Replenishing	ZINC OXIDE	Dermablue, P.C.	308da9c9-544e-d5d1-e063-6294a90aa49b	2025-12-10	Warnings	Exact identifier application number: M020
Recoverie Mineral Matte	ZINC OXIDE	Clear Day Acne Clinic	308f41de-fb14-40f9-e063-6394a90a008f	2025-12-10	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10967-669-17	10967066917	49 g in 1 JAR (10967-669-17)	49 g	2017-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30	REVLON \| Englewood Lab. INC.	2025-12-29	HUMAN OTC DRUG LABEL	3