Home NDC 10967-669 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.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 228 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COOLA Classic Body SPF 50 Guava Mango AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed13afaa-35ec-8326-e053-2995a90adaf0 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Light) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e21f5bb-e7df-b43b-e063-6394a90a0f82 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Fair) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2102c6-02ea-3a8f-e063-6394a90abf5e 2025-02-14 Warnings Exact identifier application number: M020 Sunscreen Broad Spectrum SPF 50 Vi Aesthetics ZINC OXIDE, OCTINOXATE Vi Medical Products, INC 73620765-c7c0-4bd7-82a9-00022773c928 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2297d4-3649-a749-e063-6294a90ac284 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Light) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e22cfde-10a1-3742-e063-6394a90ac097 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2e5c2add-8ed0-a990-e063-6394a90a87ea 2025-02-14 Warnings Exact identifier application number: M020 Les Duets - Shield of Helios, sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f75a5-6a3b-a129-e063-6394a90a52a0 2025-02-14 Warnings Exact identifier application number: M020 Le Mieux Naked Glow Bronzer SPF 50 SUNSCREEN YB CHEMIA LLC 46465db7-c1f0-6980-e063-6294a90a3ed8 2025-02-14 Warnings Exact identifier application number: M020 Sheer Tint Mineral SPF Serum - Light Light ZINC OXIDE Mineral Fusion brands ac6fdc35-82f8-4805-875e-2aa91aedec6f 2025-02-14 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 50 ZINC OXIDE Peer Pharm Ltd. 3989eebc-7262-4cda-84a1-ca30b638b772 2025-02-13 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 30 ZINC OXIDE Peer Pharm Ltd. 8ee9f97b-9081-4e0c-aa7a-27a31cbee17a 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Medium Deep ZINC OXIDE Peer Pharm Ltd. 45ed56e1-46cb-46de-b11a-e814a7446e57 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Light Medium ZINC OXIDE Peer Pharm Ltd. 6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Dry Touch SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC e99311c2-ed8b-6e60-e053-2a95a90a9bc2 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 525f7bae-44b8-44e4-93ea-32995eca2566 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen Sunlit SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e093b82-2a36-cc0f-e063-6394a90a4d6d 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC f93b0091-6a41-ae6e-e053-6394a90a86d7 2025-02-13 Warnings Exact identifier application number: M020 Revealer Skin-Improving Foundation SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e0a0cd6-c302-2017-e063-6394a90a60b8 2025-02-13 Warnings Exact identifier application number: M020 Hi papa KIDS MINERAL FACE SUNSCREEN SUNSCREEN GUANG DONG 3 INS TECHNOLOGY Co., Ltd 2deea723-32a0-da33-e063-6294a90accdd 2025-02-12 Warnings Exact identifier application number: M020
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