Home NDC 55550-102 Sunscreen
Product NDC 55550-102
11-digit product format 555500102
Labeler code 55550
Product ID 55550-102_1a647efd-f17c-44f1-ab72-974603f42bf7
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octinoxate, Octisalate, Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Total Resources International
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-20
Substance HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 6; 7.5; 5; 5 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 · 8 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55550-102-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55550-102-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55550-102-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 55550-102-01 8dfbde2a14a4…c9ff85d89658…
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 HOMOSALATE 6 mg/g OCTINOXATE 7.5 mg/g OCTISALATE 5 mg/g OXYBENZONE 5 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 55550-102-01 Sunscreen 1.5 g in 1 PACKET LOTION 1.5 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Homosalate ACTIVE INGREDIENT V06SV4M95S SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 Octisalate ACTIVE INGREDIENT 4X49Y0596W SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 Oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 Homosalate ACTIVE MOIETY V06SV4M95S SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 Octisalate ACTIVE MOIETY 4X49Y0596W SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 Oxybenzone ACTIVE MOIETY 95OOS7VE0Y SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 diazolidinyl urea INACTIVE INGREDIENT H5RIZ3MPW4 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 dimethicone INACTIVE INGREDIENT 92RU3N3Y1O SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 edetate sodium INACTIVE INGREDIENT MP1J8420LU SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 petrolatum INACTIVE INGREDIENT 4T6H12BN9U SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 polyoxyl 40 stearate INACTIVE INGREDIENT 13A4J4NH9I SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 povidone K30 INACTIVE INGREDIENT U725QWY32X SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 water INACTIVE INGREDIENT 059QF0KO0R SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1 xanthan gum INACTIVE INGREDIENT TTV12P4NEE SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55550-102 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL] 4 Current NDC, Legacy NDC, 1 package rows 20241228_7d4f820d-e154-428e-89c2-2e26e088ceef.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 124 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lip Crack TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37edc05c-82c3-90fe-e063-6294a90aa601 2025-12-15 Exact identifier application number: M020 Restore And Replenish ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ed8525-6ae4-4e86-e063-6294a90afeb8 2025-12-15 Exact identifier application number: M020 Sunshade Daily Sun Defense TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ee77dc-a96a-5efa-e063-6394a90affda 2025-12-15 Exact identifier application number: M020 Sunshade Mineral Sunscreen ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37df21f1-f36f-df43-e063-6294a90aea6f 2025-12-15 Exact identifier application number: M020 Tinted Moisturizing Mineral Sunscreen ZINC OXIDE EDIT EUROSPA, LLC 3751861d-3f3b-2ebd-e063-6294a90af898 2025-12-15 Exact identifier application number: M020 Non Tinted Moisturizing Mineral Sunscreen ZINC OXIDE EDIT EUROSPA, LLC 3751e278-b8b2-7bf4-e063-6394a90a4290 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 37521c60-2fee-861e-e063-6294a90ad69a 2025-12-15 Exact identifier application number: M020 MATTE Non Tinted Mineral Sunscreen ZINC OXIDE Allure Esthetics 3725d947-b1fa-3b50-e063-6394a90adf10 2025-12-15 Exact identifier application number: M020 GLOW Tinted Mineral Sunscreen ZINC OXIDE Allure Esthetics 37257bb2-d91d-6ff8-e063-6294a90a01b6 2025-12-15 Exact identifier application number: M020 Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35ce7133-badb-1bc4-e063-6294a90a7478 2025-12-15 Exact identifier application number: M020 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bee5f9-68d6-6302-e063-6394a90ada88 2025-12-15 Exact identifier application number: M020 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bfd54a-d7b7-f1a7-e063-6294a90a039b 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c03804-04e9-3d54-e063-6294a90a3407 2025-12-15 Exact identifier application number: M020 Deflectin Tinted Mineral Sunscreen ZINC OXIDE AEON AESTHETICS LLC 35d14660-8900-2cb0-e063-6394a90a317d 2025-12-15 Exact identifier application number: M020 Mineral Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf36c1-50c9-e848-e063-6294a90a6658 2025-12-15 Exact identifier application number: M020 Flash Invisible Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d2489e-4978-4fc3-e063-6294a90adfcc 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c010ad-e25d-f197-e063-6294a90a0efb 2025-12-15 Exact identifier application number: M020 Flash Tinted Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d28590-e746-7996-e063-6294a90ac7d8 2025-12-15 Exact identifier application number: M020 Mineral Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf03f4-200a-5643-e063-6394a90a9e02 2025-12-15 Exact identifier application number: M020 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55550-102-01 55550010201 1.5 g in 1 PACKET (55550-102-01) 1.5 g 2023-01-20 No No Current