Home NDC 71070-868 JACKET SPF-50 Broad Spectrum Sunscreen
Product NDC 71070-868
11-digit product format 710700868
Labeler code 71070
Product ID 71070-868_20ce424e-ca59-9b97-e063-6394a90abfba
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form LOTION
Route TOPICAL
Labeler BALSHI MD DERMACEUTICALS
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-15
Substance ZINC OXIDE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 60; 100; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL
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 Broad Spectrum Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 60 mg/mL HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 50 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71070-868-04 JACKET SPF-50 Broad Spectrum Sunscreen 120 mL in 1 TUBE LOTION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71070-868 JACKET SPF-50 BROAD SPECTRUM SUNSCREEN (ZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [BALSHI MD DERMACEUTICALS] 3 Current NDC, Legacy NDC, 1 package rows 20240830_fcc45edd-098c-4f27-9712-0db36cfa0fdc.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 162 of 353 · 7,041 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 71070-868-04 71070086804 120 mL in 1 TUBE (71070-868-04) 120 ml 2019-04-15 0000-00-00 No No Current