Cream

Product NDC: 61354-115
11-digit product format: 613540115
Labeler code: 61354
Product ID: 61354-115_08a1e862-b55b-fb84-e063-6294a90a016a
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-26
Substance: ZINC OXIDE
Active strength: 21.76 mg/100mg
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: Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	21.76 mg/100mg

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
08a1e862-b55a-fb84-e063-6294a90a016a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-115-01	Cream	100 mg in 1 TUBE	CREAM	100		1
61354-115-02	Cream	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-115	CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	1	Current NDC, 2 package rows	20231030_08a1e862-b55a-fb84-e063-6294a90a016a.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 77 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	166e293f-3874-4fe6-8c20-2162b0d11cf1	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b048c7a5-8a71-47ea-945c-44a2d663dfa7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e0463aa0-8e56-4dcd-8cd8-776e8a3915f2	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 10N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	038939d6-b9a5-4cb6-a818-6f7cf3f106fa	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	03c7ca69-86f1-420c-9c4c-0bf2e8553c94	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ff6a85a4-b0c5-4c2e-a698-bb315203f51b	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	262b4cfc-71c3-485e-906f-a88fe33035a8	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 8N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	30964b87-1d7c-4dd1-8ab2-bf9b8eb2ee03	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2cb4bad3-57d6-4e67-88ec-1776870c3eba	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00 Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ffd1ba9e-dd64-422a-bd69-596b5d80554d	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	64943a01-5193-4c04-b623-33ceb09f10fd	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	df2e2d3f-8876-4197-bdfa-339b4f6a7571	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6cb5d7fa-4d40-46bd-9ef3-14368578cb33	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ae1e74f1-eb31-4da1-8b24-dae692d3637e	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a5ce5568-708a-4af1-aa06-ea643c898bb1	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4fc4ce51-000a-42ee-952f-b4ce5f5d8a60	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ade16145-5267-4f01-bd99-f507087583f3	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4b23d8e4-b0c3-44d7-b239-a2c7ae442a2d	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72471612-1ae0-493c-87c7-bf7257310e70	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	881ad126-d93f-4782-8ece-600d41a254d7	2026-01-16	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61354-115-01	61354011501	100 mg in 1 TUBE	100 mg				Historical
61354-115-02	61354011502	1 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01)	1 tube	2023-10-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Self Reflect Probiotic Moisturizing Zinc Oxide Sunscreen Broad Spectrum SPF 32	Oxygen Development LLC	2023-10-26	HUMAN OTC DRUG LABEL	1