Home NDC 76138-221 5299 SUNSCREEN
Product NDC 76138-221
11-digit product format 761380221
Labeler code 76138
Product ID 76138-221_1cee9f13-bc8e-13e8-e063-6294a90a0598
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octocrylene, Octisalate
Dosage form LOTION
Route TOPICAL
Labeler Innovation Specialties
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-10
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 30; 100; 100; 50 mg/mL; 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 5299 SUNSCREEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 100 mg/mL OCTOCRYLENE 100 mg/mL OCTISALATE 50 mg/mL
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 76138-221-06 5299 SUNSCREEN 20 mL in 1 BOTTLE LOTION 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76138-221 5299 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES] 3 Current NDC, Legacy NDC, 1 package rows 20240712_f3db6bd8-cc6f-4af5-809d-95fb05f6732f.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 41 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light Medium ZINC OXIDE ZO Skin Health, Inc. 4fabe9d0-27fe-230f-e063-6294a90a9ac0 2026-04-17 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-Tan ZINC OXIDE ZO Skin Health, Inc. 4fac82b7-d685-2a0d-e063-6394a90aa795 2026-04-17 Warnings Exact identifier application number: M020 SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50 SUNSCREEN Saltair Body LLC 4fae649d-f60e-0275-e063-6294a90a1ea5 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e64-2eab-1219-e063-6294a90a79a8 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cd8a3-3d62-83ac-e063-6394a90a4afa 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e2424f4-0011-42b0-e063-6394a90a780d 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cfaea-b71f-2956-e063-6294a90a4f20 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316d1515-6092-a7d6-e063-6394a90ab8b2 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e70-6ec3-5711-e063-6394a90a3879 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e241343-db63-3f1c-e063-6394a90ab538 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316df5fe-0574-d59f-e063-6294a90af8b9 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316c5d69-46f4-7677-e063-6294a90a610f 2026-04-17 Warnings Exact identifier application number: M020 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 PML NYC, LLC 316d905f-232c-d8a2-e063-6394a90adbc9 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N PML NYC, LLC 316ea01b-4bff-55be-e063-6394a90add94 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 410 N PML NYC, LLC 316e97bc-4b96-ba6e-e063-6294a90a7648 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c781d7-9d48-892f-e053-2a95a90aca86 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c757b4-6c92-18f0-e053-2a95a90a246d 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c76a82-dc87-35e7-e053-2995a90ae310 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7ac71-3f38-52b2-e053-2a95a90ab54e 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7b929-7492-f072-e053-2995a90a1ca3 2026-04-17 Warnings 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 76138-221-06 76138022106 20 mL in 1 BOTTLE (76138-221-06) 20 ml 2022-05-10 0000-00-00 No No Current