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

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
IngredientStrength
ZINC OXIDE22.3 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83695-002-01SPF50 Moisturizer with Aloe, Green Tea and Shea Butter113 g in 1 BOTTLECREAM1131
83695-002-01SPF50 Moisturizer with Aloe, Green Tea and Shea Butter1 in 1 CARTONCREAM11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83695-002-01836950002011 BOTTLE in 1 CARTON (83695-002-01) / 113 g in 1 BOTTLE1 bottle2026-03-01NoNoHistorical