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 127 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COOLA CLASSIC SUNSCREEN FRAGRANCE FREE AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC cfc21b1a-4a26-1573-e053-2995a90a2d50 2025-12-14 Warnings Exact identifier application number: M020 Kopari Sunglaze Sheer Body Mist Sunscreen SPF42 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kopari Beauty 7c96b799-e24d-473f-8f0a-3fad83d5ed48 2025-12-14 Warnings Exact identifier application number: M020 WOODSLEEP Sunscreen Balm TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 45cfc7ed-34a6-1f45-e063-6394a90a902b 2025-12-13 Warnings Exact identifier application number: M020 Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50 ZINC OXIDE 24% UNIVERSKIN 45d242de-cbd8-e7ea-e063-6394a90aaebf 2025-12-13 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE SPF 50 ALAINA HEALTHCARE PRIVATE LIMITED b7847d4f-2517-4b58-8e31-676c9d6e484d 2025-12-12 Warnings Exact identifier application number: M020 Lip Protecting TITANIUM DIOXIDE, ZINC OXIDE JOHANNA'S SKIN CARE 3544b8f2-2651-4c01-e063-6394a90ae53d 2025-12-12 Exact identifier application number: M020 Tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE JOHANNA'S SKIN CARE 3544faa1-ebdf-5dbd-e063-6394a90a7631 2025-12-12 Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 40323dfa-29e4-1464-e063-6294a90aa65c 2025-12-12 Warnings Exact identifier application number: M020 Zinc 20Percent SPF 40 ZINC OXIDE JOHANNA'S SKIN CARE 3545ed3e-b42f-d29d-e063-6394a90a8efe 2025-12-12 Exact identifier application number: M020 Replenishing Daily Protection Non-Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 40332cf3-e4e5-0c00-e063-6394a90a683d 2025-12-12 Warnings Exact identifier application number: M020 Replenishing Daily Protection Non-Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 4032913b-4bc3-6920-e063-6294a90a6e2d 2025-12-12 Warnings Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 4032f0b0-c083-d227-e063-6394a90a3068 2025-12-12 Warnings Exact identifier application number: M020 Everyday Mineral Sunscreen ZINC OXIDE MYRENE DULAY-MARTINEZ 396d952b-22ff-567f-e063-6394a90a8c68 2025-12-12 Exact identifier application number: M020 Everyday Mineral Sunscreen ZINC OXIDE MYRENE DULAY-MARTINEZ 396dfc9c-b6c0-5892-e063-6394a90a110c 2025-12-12 Exact identifier application number: M020 KawaKids KawaSun - Premium Mineral Sunscreen SPF 50 ZINC OXIDE LCA COSMETICS LLC 1f41f64b-d707-08e2-e063-6294a90aa924 2025-12-12 Warnings Exact identifier application number: M020 KawaKids KawaSun - Premium On-The-Go Mineral Sunscreen SPF 50 ZINC OXIDE LCA COSMETICS LLC 1f4341f7-b499-3b73-e063-6394a90a75b8 2025-12-12 Warnings Exact identifier application number: M020 Advanced Mineral Sunscreen ZINC OXIDE Charisma Skin 351f7f72-c426-e42f-e063-6294a90a4b3a 2025-12-12 Exact identifier application number: M020 Advanced Mineral Sunscreen ZINC OXIDE Charisma Skin 351f06f3-9deb-4c1a-e063-6394a90ad766 2025-12-12 Exact identifier application number: M020 Daily Mineral Protection ZINC OXIDE Charisma Skin 352d72f6-06b9-6fdc-e063-6294a90ab448 2025-12-12 Exact identifier application number: M020 Daily Mineral Protection ZINC OXIDE Charisma Skin 352dc69b-86d0-aa15-e063-6294a90a5e4c 2025-12-12 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