Home NDC 71070-768 JACKET SPF 50
Product NDC 71070-768
11-digit product format 710700768
Labeler code 71070
Product ID 71070-768_0974579b-6f81-6b47-e063-6294a90a0217
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE
Dosage form CREAM
Route TOPICAL
Labeler Balshi MD Dermaceuticals
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-18
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 75; 75; 50; 50 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 JACKET SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 75 mg/g OCTINOXATE 75 mg/g OCTISALATE 50 mg/g OXYBENZONE 50 mg/g
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 71070-768-04 JACKET SPF 50 1 in 1 CARTON CREAM 1 3 71070-768-04 JACKET SPF 50 113 g in 1 BOTTLE CREAM 113 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71070-768 JACKET SPF 50 (ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE) CREAM [BALSHI MD DERMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20231106_b82b8a46-8009-416e-8718-296a23106914.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 71070-768-04 71070076804 1 BOTTLE in 1 CARTON (71070-768-04) / 113 g in 1 BOTTLE 1 bottle 2016-11-18 0000-00-00 No No Current