Home NDC 83677-610 Hale and Hush Broad Spectrum SPF 30
Product NDC 83677-610
11-digit product format 836770610
Labeler code 83677
Product ID 83677-610_4839683f-5b57-ca9b-e063-6294a90a7f5f
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Eclectic Solutions LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-04-02
Substance ZINC OXIDE
Active strength 13.5 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 Hale and Hush Broad Spectrum SPF 30
Brand name suffix SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 13.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
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 83677-610-58 Hale and Hush Broad Spectrum SPF 30SPF 30 55 g in 1 BOTTLE, DISPENSING CREAM 55 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83677-610 HALE AND HUSH BROAD SPECTRUM SPF 30 SPF 30 (ZINC OXIDE) CREAM [ECLECTIC SOLUTIONS LLC] 3 Current NDC, 1 package rows 20241201_0530904f-b02c-d8cf-e063-6294a90aa5a7.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 353 · 7,041 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83677-610-58 83677061058 55 g in 1 BOTTLE, DISPENSING (83677-610-58) 55 g 2018-04-02 No No Current