Home NDC 58466-108 celazome
Product NDC 58466-108
11-digit product format 584660108
Labeler code 58466
Product ID 58466-108_f1bea67c-e6e1-44cf-b088-53a00d157b70
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 60; 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58466-108-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58466-108-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58466-108-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58466-108-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58466-108-04 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58466-108-04 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58466-108-04 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 29 Active with DNArescue
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYBENZONE 60 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 58466-108-04 celazomeMoisturizing SPF 29 Active with DNArescue 113 g in 1 BOTTLE, DISPENSING CREAM 113 3 58466-108-04 celazomeMoisturizing SPF 29 Active with DNArescue 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 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 .alpha.-tocopherol acetate INACTIVE INGREDIENT 9E8X80D2L0 CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 Diethanolamine Cetyl Phosphate INACTIVE INGREDIENT 4UG0316V9S CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 dimethicone INACTIVE INGREDIENT 92RU3N3Y1O CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 dioctyl maleate INACTIVE INGREDIENT OD88G8439L CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 sorbitol INACTIVE INGREDIENT 506T60A25R CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 trolamine INACTIVE INGREDIENT 9O3K93S3TK CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (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 58466-108 CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20181117_99fb90ca-6527-459b-8af2-627ea9abe11b.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 109 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bella Blue Skin Care Tinted Sunscreen ZINC OXIDE BELLA BLU STUDIOS INC 3f663fe5-fdfe-d793-e063-6394a90a4f0b 2025-12-17 Warnings Exact identifier application number: M020 Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3aadc018-edbb-033b-e063-6394a90afbe7 2025-12-17 Warnings Exact identifier application number: M020 Non-Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3ab0298d-b2d0-591e-e063-6394a90a3177 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3cce3120-748e-a7fd-e063-6394a90a4d51 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3ccea6c0-8c27-6b26-e063-6294a90a0931 2025-12-17 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE JKH Aesthetics LLC 369c1d16-5980-e1dc-e063-6394a90a3104 2025-12-17 Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3d5a2662-02e3-3a95-e063-6294a90a8120 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3d5ab3f6-10b9-2a21-e063-6294a90a3428 2025-12-17 Warnings Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JKH Aesthetics LLC 369ccb8f-d9b6-1fd2-e063-6394a90ace20 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364cafdd-fe86-cb23-e063-6394a90afb09 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364d2231-3db3-0a59-e063-6394a90a6777 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d4f6a7-1115-1efa-e063-6294a90a20c4 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d69eb5-597d-14a0-e063-6394a90a0a49 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d45700-fc41-ef54-e063-6394a90abcc3 2025-12-17 Exact identifier application number: M020 Gentle Mineral SPF 40 Tinted ZINC OXIDE ELIZA ARAKELIAN 36d66cde-1f90-32b5-e063-6294a90acb34 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d7148b-b1c4-a6a9-e063-6294a90af92f 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d85902-fbd2-ba74-e063-6294a90acfc3 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad1330-a8bf-e8f8-e063-6394a90acb02 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d9a8f3-7760-57f3-e063-6394a90a1a1e 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d7a18b-5a12-84a9-e063-6394a90a7e38 2025-12-17 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 58466-108-04 58466010804 1 BOTTLE, DISPENSING in 1 CARTON (58466-108-04) / 113 g in 1 BOTTLE, DISPENSING 2015-10-01 0000-00-00 No No Current