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 219 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
City Skin Age Defense Broad Spectrum SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Murad, LLC	f8c572a2-b4bc-49e9-95df-359f05bd69b7	2025-03-28	Warnings	Exact identifier application number: M020
HEB SPF 50 Rejuvenate Sunscreen with Moisturizing Oils and Vitamins Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314c54ed-32f8-5c20-e063-6394a90a0af5	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( blueberry) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	314f8990-4b33-e2b1-e063-6394a90a4d79	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( bubble gum) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	31507a62-09a7-6bcc-e063-6394a90aa575	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( Birthday cake) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3152bd5d-474f-e392-e063-6294a90aa930	2025-03-27	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Bubble Gum Flavored	LIP BALM SPF15 BUBBLE GUM FLAVORED	LS Promotions Inc	3152bd5d-4750-e392-e063-6294a90aa930	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( Cocount Pina Colada) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	31538f32-9f71-bd40-e063-6394a90a1cd8	2025-03-27	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Birthday Cake flavored	LIP BALM SPF15 BIRTHDAY CAKE FLAVORED	LS Promotions Inc	3153bc6a-8f60-ea37-e063-6294a90acd97	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( Apple pie) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3153e1fe-1c43-def0-e063-6294a90a6b3a	2025-03-27	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Strawberry Shortcake flavored	LIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVORED	LS Promotions Inc	315402e4-c1ec-150f-e063-6294a90ae29e	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( Vanilla) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3154206c-00b3-e5e3-e063-6394a90afee8	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( Passion Fruit) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	31544568-c556-72b2-e063-6294a90ace91	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( Peppermint) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	31548583-ecc7-2e1e-e063-6394a90a2402	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( strawberry) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3154b0f0-2025-4514-e063-6394a90a70c4	2025-03-27	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Tropical Punch Flavored	LIP BALM SPF15 TROPICAL PUNCH FLAVORED	LS Promotions Inc	3154ae45-e075-f53b-e063-6294a90aed5b	2025-03-27	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Passion Fruit flavored	LIP BALM SPF15 PASSION FRUIT FLAVORED	LS Promotions Inc	31552e96-980c-8120-e063-6294a90af3da	2025-03-27	Warnings	Exact identifier application number: M020
natural lip balm SPF15( tropical punch) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	315579e7-e1fb-d6f5-e063-6294a90af06a	2025-03-27	Warnings	Exact identifier application number: M020
Shea Moisture	NOURISHED AND RADIANT BROAD SPECTRUM SPF 30 SUNSCREEN FACE LOTION	Conopco d/b/a/ Unilever	3159be1c-9678-5b1a-e063-6294a90acd08	2025-03-27	Warnings	Exact identifier application number: M020
CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30	HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE	LOreal USA Products Inc	7d9e8c07-d295-4c8e-a52f-bdb509dc489b	2025-03-27	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Mattifying Oil plus Pore Control SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	8d89ebf5-bcd5-4fde-a7d4-059023e00f33	2025-03-27	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