Home NDC 61619-866-01 Pro-Tect Sunscreen for Professionals
Product NDC 61619-866
Requested package NDC 61619-866-01
11-digit product format 616190866
Labeler code 61619
Product ID 61619-866_b79d7feb-288f-d13f-e053-2a95a90ab7b1
Type HUMAN OTC DRUG
Nonproprietary name Meradimate, Octinoxate, Octisalate, Oxybenzone
Dosage form LOTION
Route CUTANEOUS
Labeler A-Cute Derm, Incorporated
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2016-02-08
Marketing end 0000-00-00
Substance OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
Active strength 75 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61619-866-01 Pro-Tect Sunscreen for Professionals 29.6 mL in 1 BOTTLE, PLASTIC LOTION 29.6 5 61619-866-02 Pro-Tect Sunscreen for Professionals 59.1 mL in 1 BOTTLE, PLASTIC LOTION 59.1 5 61619-866-04 Pro-Tect Sunscreen for Professionals 118.3 mL in 1 BOTTLE, PLASTIC LOTION 118.3 5 61619-866-08 Pro-Tect Sunscreen for Professionals 236.6 mL in 1 BOTTLE, PLASTIC LOTION 236.6 5 61619-866-32 Pro-Tect Sunscreen for Professionals 946.4 mL in 1 BOTTLE, PLASTIC LOTION 946.4 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MERADIMATE ACTIVE INGREDIENT J9QGD60OUZ PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 MERADIMATE ACTIVE MOIETY J9QGD60OUZ PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 OCTISALATE ACTIVE MOIETY 4X49Y0596W PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 .ALPHA.-TOCOPHEROL ACETATE, DL- INACTIVE INGREDIENT WR1WPI7EW8 PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 809Y72KV36 PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 CETYL DIMETHICONE 45 INACTIVE INGREDIENT IK315POC44 PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 DIETHANOLAMINE CETYL PHOSPHATE INACTIVE INGREDIENT 4UG0316V9S PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 EICOSYL POVIDONE INACTIVE INGREDIENT XQQ9MKE2BJ PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61619-866 PRO-TECT SUNSCREEN FOR PROFESSIONALS (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] 5 Legacy NDC, 5 package rows 20201230_9604b7d9-d7fc-4cce-ad11-befb7c281fff.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61619-866-01 61619086601 29.6 mL in 1 BOTTLE, PLASTIC (61619-866-01) 29.6 ml 2016-02-08 0000-00-00 No No Current