Zinc Oxide 20%

Product NDC
69630-004
11-digit product format
696300004
Labeler code
69630
Product ID
69630-004_4db2b8a1-b627-9f7b-e063-6394a90a1fa9
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen SPF 50
Dosage form
LOTION
Route
TOPICAL
Labeler
The Soleil Group, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-09
Substance
ZINC OXIDE
Active strength
20 g/100mL
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
Zinc Oxide 20%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

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
69630-004-01Zinc Oxide 20%1 in 1 CARTONLOTION12
69630-004-01Zinc Oxide 20%16 mL in 1 BOTTLELOTION162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69630-004-01696300004011 BOTTLE in 1 CARTON (69630-004-01) / 16 mL in 1 BOTTLE1 bottle2025-12-01NoNoCurrent