Home NDC 58466-901 celazome
Product NDC 58466-901
11-digit product format 584660901
Labeler code 58466
Product ID 58466-901_586f453e-4b57-49b8-8139-91fa03099f92
Type HUMAN OTC DRUG
Nonproprietary name OXYBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE
Dosage form CREAM
Route TOPICAL
Labeler Dermazone LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-10-01
Substance OXYBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE
Active strength 50; 75; 50; 50 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 · 26 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 2025-04-01 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 58466-901-04 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 celazome
Brand name suffix Moisturizing SPF 30 Active
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYBENZONE 50 mg/g OCTINOXATE 75 mg/g OCTISALATE 50 mg/g HOMOSALATE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58466-901-04 celazomeMoisturizing SPF 30 Active 113 g in 1 BOTTLE, DISPENSING CREAM 113 3 58466-901-04 celazomeMoisturizing SPF 30 Active 1 in 1 CARTON CREAM 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HOMOSALATE ACTIVE INGREDIENT V06SV4M95S CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 .alpha.-tocopherol acetate INACTIVE INGREDIENT 9E8X80D2L0 CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 Diethanolamine Cetyl Phosphate INACTIVE INGREDIENT 4UG0316V9S CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 dimethicone INACTIVE INGREDIENT 92RU3N3Y1O CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 dioctyl maleate INACTIVE INGREDIENT OD88G8439L CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 sorbitol INACTIVE INGREDIENT 506T60A25R CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 trolamine INACTIVE INGREDIENT 9O3K93S3TK CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58466-901 CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20181120_5ec1510d-1465-4849-9e23-f16e11ff0e65.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 131 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Mineral Sunscreen ZINC OXIDE SPECKTRA6 LLC 374e1c8e-5c5c-9198-e063-6294a90a3b88 2025-12-11 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE SPECKTRA6 LLC 374f063a-1ea6-2fcc-e063-6394a90ac574 2025-12-11 Exact identifier application number: M020 Defend Tinted Mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE SMOOTH ESTHETICS LLC 36eb9fc0-25d7-cfb4-e063-6394a90a2e22 2025-12-11 Exact identifier application number: M020 Sheer Tinted Sunscreen SPF40 TITANIUM DIOXIDE, ZINC OXIDE SIMPLICITY SKIN, SPA & BOUTIQUE, LLC 36ebdb85-ce8a-d7e0-e063-6394a90a2261 2025-12-11 Exact identifier application number: M020 Solar Shield Face and Body SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b138432-19e5-e757-e063-6294a90a4cbe 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Primer SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b149758-bbe1-bd66-e063-6294a90afe78 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Face and Body SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b14caa3-f58e-b9ab-e063-6394a90a9695 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Primer SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b152e27-3917-eb7e-e063-6394a90a1f43 2025-12-11 Warnings Exact identifier application number: M020 Mineral Lip Protection TITANIUM DIOXIDE, ZINC OXIDE COLETTE TOMASI LLC 3727b29f-fe51-0b15-e063-6394a90a780b 2025-12-11 Exact identifier application number: M020 Daytime Moisture SPF40 ZINC OXIDE COLETTE TOMASI LLC 372773b6-fc37-c74b-e063-6294a90a7bf2 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c291a-7839-8486-e063-6294a90a5af3 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373cef98-a61d-dd36-e063-6394a90a7c3b 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373d1e6c-9c32-20f5-e063-6294a90af86f 2025-12-11 Exact identifier application number: M020 Prevention 2 Acne Safe Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c0ab0-8828-542b-e063-6394a90a8633 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373ddad0-ed33-a233-e063-6294a90a19cd 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37263083-b24f-5a71-e063-6294a90aee7d 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373d4fad-141c-0904-e063-6394a90a9759 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37265b3d-92ef-ef4a-e063-6294a90a8d95 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373d902f-f7b6-298b-e063-6394a90a9307 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726c177-2912-a6cc-e063-6394a90a0043 2025-12-11 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58466-901-04 58466090104 1 BOTTLE, DISPENSING in 1 CARTON (58466-901-04) / 113 g in 1 BOTTLE, DISPENSING 2015-10-01 0000-00-00 No No Current