Home NDC 55910-012 Sunscreen
Product NDC 55910-012
11-digit product format 559100012
Labeler code 55910
Product ID 55910-012_4c10c12b-2e1f-8b32-e063-6294a90a18e9
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate,Otisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Old East Main Co.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 150 mg/g OCTISALATE 50 mg/g OCTOCRYLENE 100 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55910-012-14 Sunscreen 156 g in 1 CAN SPRAY 156 20 55910-012-15 Sunscreen 258 g in 1 CAN SPRAY 258 20 55910-012-39 Sunscreen 312 g in 1 CAN SPRAY 312 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-012 SUNSCREEN (AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE) SPRAY [OLD EAST MAIN CO] 18 Current NDC, Legacy NDC, 3 package rows 20241013_2ea288fe-815d-4568-9592-55ea428448fa.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 125 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf708c-244e-63a8-e063-6394a90a3b96 2025-12-15 Exact identifier application number: M020 Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35cead50-86a7-2cf2-e063-6294a90a5f99 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e81e8e-0ba7-93e6-e063-6294a90a4e62 2025-12-15 Exact identifier application number: M020 Sacred Aura ZINC OXIDE IRIA SKIN OASIS LLC 36eaaa54-e288-6590-e063-6394a90a403d 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e84147-5dcd-517a-e063-6394a90a54ee 2025-12-15 Exact identifier application number: M020 Sacred Glow ZINC OXIDE IRIA SKIN OASIS LLC 36ead65c-a46c-7395-e063-6394a90a9e04 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e91877-c4c4-7fa3-e063-6294a90a1326 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e880af-debc-657f-e063-6394a90ab6ff 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e8b631-03e7-c1de-e063-6294a90aa530 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e957cf-cfa5-b122-e063-6294a90a78ce 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9c2f3-ea89-0de3-e063-6394a90a9fb6 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9958b-cc5c-f7ff-e063-6394a90ac80d 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d8e8ba-a3dd-257d-e063-6294a90a30d6 2025-12-15 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e9e8d7-3fcf-1e94-e063-6394a90a8dc6 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d968df-5168-61bf-e063-6294a90a94b7 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d45b48-e08d-ef40-e063-6394a90a635c 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d439fb-b9cf-2774-e063-6294a90ae885 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9b48d-e3db-6ae2-e063-6294a90abbf5 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9d83b-7da7-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN & ACNE 36d3ebc0-1de6-1998-e063-6294a90a02e6 2025-12-15 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 55910-012-14 55910001214 156 g in 1 CAN (55910-012-14) 156 g 2019-10-01 0000-00-00 No No Current 55910-012-15 55910001215 258 g in 1 CAN (55910-012-15) 258 g 2019-10-01 0000-00-00 No No Current 55910-012-39 55910001239 312 g in 1 CAN (55910-012-39) 312 g 2019-10-01 0000-00-00 No No Current