Home NDC 83695-002 SPF50 Moisturizer with Aloe, Green Tea and Shea Butter
Product NDC 83695-002
11-digit product format 836950002
Labeler code 83695
Product ID 83695-002_4bbf94a2-1af9-523e-e063-6394a90a9fc5
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Audrey Morris Cosmetics International, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-01
Substance ZINC OXIDE
Active strength 22.3 g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 SPF50 Moisturizer with Aloe, Green Tea and Shea Butter
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 22.3 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 83695-002-01 SPF50 Moisturizer with Aloe, Green Tea and Shea Butter 113 g in 1 BOTTLE CREAM 113 1 83695-002-01 SPF50 Moisturizer with Aloe, Green Tea and Shea Butter 1 in 1 CARTON CREAM 1 1
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 Sample Exclude flag Status 83695-002-01 83695000201 1 BOTTLE in 1 CARTON (83695-002-01) / 113 g in 1 BOTTLE 1 bottle 2026-03-01 No No Current