Home NDC 68577-197 SOLAR MILK SPF50
Product NDC 68577-197
11-digit product format 685770197
Labeler code 68577
Product ID 68577-197_29fe4dad-d1fc-e750-e063-6294a90ab307
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler COSMAX USA, CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 3; 15; 10; 5 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 SOLAR MILK SPF50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 mg/mL HOMOSALATE 15 mg/mL OCTOCRYLENE 10 mg/mL OCTISALATE 5 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68577-197-00 SOLAR MILK SPF50 1 in 1 CARTON GEL 1 1 68577-197-00 SOLAR MILK SPF50 50 mL in 1 BOTTLE GEL 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68577-197 SOLAR MILK SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [COSMAX USA, CORPORATION] 1 Current NDC, 2 package rows 20241227_29fe4dad-d1fb-e750-e063-6294a90ab307.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 137 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ProtectME Tinted Mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE PUREFECTION LA, INC. 33dccd5d-8db1-f699-e063-6394a90a59a2 2025-12-10 Exact identifier application number: M020 Protect ME Non Tinted Mineral SPF 40 ZINC OXIDE PUREFECTION LA, INC. 34a2d716-b853-752e-e063-6394a90a52e2 2025-12-10 Exact identifier application number: M020 Tinted Mineral Moisturizing Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ABOUT FACE AESTHETICS, INC. 364728b4-e0ff-8466-e063-6394a90a0089 2025-12-10 Exact identifier application number: M020 tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d42661-e511-1dfc-e063-6294a90a9ed7 2025-12-10 Exact identifier application number: M020 non-tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d3ef95-621c-f193-e063-6294a90ac3ee 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen tinted ZINC OXIDE Skin & Bare It LLC 35d45df5-e9bf-1a08-e063-6294a90ae04f 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen non-tinted ZINC OXIDE Skin & Bare It LLC 361ef750-0f0e-bd01-e063-6294a90a0020 2025-12-10 Exact identifier application number: M020 bare skin smooth mineral tint ZINC OXIDE Skin & Bare It LLC 361f2933-73d5-a9d7-e063-6394a90abb3c 2025-12-10 Exact identifier application number: M020 Smoothing Mineral Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE DANIEL BEHROOZAN MD A MEDICAL CORPORATION 32721b87-aef1-d759-e063-6394a90a40d3 2025-12-10 Exact identifier application number: M020 Non-Tinted Mineral Stick TITANIUM DIOXIDE, ZINC OXIDE Shelley Bennett Skincare 326e9a14-5fb6-6a6e-e063-6294a90adece 2025-12-10 Exact identifier application number: M020 3-in-1 Daily Vanishing Tinted Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 325dae60-01cc-a120-e063-6294a90a2ef2 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 326e49b8-e21c-0df0-e063-6394a90a2ebc 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE SHELLEY BENNET SKINCARE 325df1f8-1678-c07c-e063-6294a90a96fb 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bafa0b-d253-c263-e063-6394a90ad1e4 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35ba578f-a842-7eec-e063-6394a90a1165 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb3b36-3886-ea8e-e063-6394a90a5257 2025-12-10 Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bc3994-1f72-2bbf-e063-6294a90ac2f1 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bccadf-6fc8-abd0-e063-6294a90aaa2e 2025-12-10 Exact identifier application number: M020 Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb9341-355f-4910-e063-6294a90a8c15 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bd61ff-0d66-a9b3-e063-6394a90ad940 2025-12-10 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 68577-197-00 68577019700 1 BOTTLE in 1 CARTON (68577-197-00) / 50 mL in 1 BOTTLE 1 bottle 2024-09-01 No No Current