Home NDC 67015-2035 HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
Product NDC 67015-2035
11-digit product format 670152035
Labeler code 67015
Product ID 67015-2035_5d193517-de3c-e99d-e063-6394a90a9010
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Pierre Fabre USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-03
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 4.9; 13.7 g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 4.9 g/100g TITANIUM DIOXIDE 13.7 g/100g
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67015-2035-0 HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey 10 g in 1 CONTAINER CREAM 10 4 67015-2035-1 HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67015-2035 HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 HONEY (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PIERRE FABRE USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240131_8ab57a9b-db89-1bf2-e053-2995a90a303a.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 45 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 67015-2035-0 67015203500 10 g in 1 CONTAINER 10 g Historical 67015-2035-1 67015203501 1 CONTAINER in 1 CARTON (67015-2035-1) / 10 g in 1 CONTAINER (67015-2035-0) 1 container 2019-06-03 0000-00-00 No No Current