Home NDC 84281-477 SUMMER GELEE SPF-30
Product NDC 84281-477
11-digit product format 842810477
Labeler code 84281
Product ID 84281-477_171b43a9-7f61-f8ff-e063-6294a90ab5fb
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler SUMMER GELEE LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-06
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 100; 50; 50 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 SUMMER GELEE SPF-30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 84281-477-00 SUMMER GELEE SPF-30 92.26 mL in 1 TUBE GEL 92.26 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84281-477 SUMMER GELEE SPF-30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [SUMMER GELEE LLC] 1 Current NDC, 1 package rows 20240507_bc85db65-2acc-4b39-9189-f8916c487b61.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 39 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HYDRA SPF 34 HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE Drmtlgy, LLC 31e41ed5-8498-4e2d-928a-c15ca99775e4 2026-04-21 Warnings Exact identifier application number: M020 FORGESKIN MINERAL TALLOW SUNSCREEN GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD 4fe913f4-b0be-dc53-e063-6294a90a363c 2026-04-20 Warnings Exact identifier application number: M020 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE SEORIN COMPANY Co., Ltd. 228dcd68-aaba-0451-e063-6394a90a8ad0 2026-04-20 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f900db18-5fe2-1d74-e053-6394a90a3ca2 2026-04-20 Warnings Exact identifier application number: M020 Biore UV Aqua Rich OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA 2bc23bb5-86bb-7915-e063-6394a90a9d72 2026-04-20 Warnings Exact identifier application number: M020 ETUDE SunPrise Mild Airy Finish Sunstick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ETUDE CORPORATION 25abc744-5b62-acb4-e063-6394a90af110 2026-04-19 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b05e-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b060-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7d9f4-986f-70f7-e053-2a95a90a4f8a 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c81845-afcb-18ac-e053-2a95a90abdbe 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c83245-a40c-8f05-e053-2a95a90a0521 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c84047-fd3b-ea66-e053-2a95a90ae9aa 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c623aa-3846-b7f4-e053-2995a90aecb5 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c585ff-88de-e29c-e053-2a95a90af4d4 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c852de-4c36-6d93-e053-2995a90aff61 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c86288-bb22-03b1-e053-2995a90a3161 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8742f-1060-48bc-e053-2995a90a31c2 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c4eedc-12a0-6418-e053-2a95a90a55e7 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8849a-6624-6987-e053-2a95a90a4546 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8ac70-a8c8-2f07-e053-2a95a90a3d01 2026-04-18 Warnings 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 84281-477-00 84281047700 92.26 mL in 1 TUBE (84281-477-00) 92.26 ml 2024-05-06 No No Current