Home NDC 40046-0063 MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50
Product NDC 40046-0063
11-digit product format 400460063
Labeler code 40046
Product ID 40046-0063_2a15b983-41fb-edf5-e063-6394a90a0315
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE
Dosage form LOTION
Route TOPICAL
Labeler MAKEUP ART COSMETICS
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-02
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 30; 50; 50; 27; 30 mg/mL; 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 MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 50 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 27 mg/mL OXYBENZONE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40046-0063-1 MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50 1 in 1 CARTON LOTION 1 8 40046-0063-1 MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50 30 mL in 1 TUBE LOTION 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40046-0063 MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MAKEUP ART COSMETICS] 8 Current NDC, Legacy NDC, 2 package rows 20241227_c26ef380-1309-4a41-862f-eb319d38673d.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 40046-0063-1 40046006301 1 TUBE in 1 CARTON (40046-0063-1) / 30 mL in 1 TUBE 1 tube 2012-02-02 0000-00-00 No No Current