Skin Apeel Ageless Defense SPF 40 Broad Spectrum

Product NDC: 83628-208
11-digit product format: 836280208
Labeler code: 83628
Product ID: 83628-208_f29ee2dc-e607-4c1f-9cf0-aad7cb79dc98
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Skin Apeel, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-09-17
Substance: ZINC OXIDE
Active strength: 160 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	83628-208		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	83628-208	83628-208-50	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: Skin Apeel Ageless Defense SPF 40 Broad Spectrum
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/g

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
c3bbe779-b012-4f19-8b90-2c7a4dd88617	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83628-208-50	Skin Apeel Ageless Defense SPF 40 Broad Spectrum	50 g in 1 BOTTLE, PUMP	CREAM	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83628-208	SKIN APEEL AGELESS DEFENSE SPF 40 BROAD SPECTRUM (ZINC OXIDE) CREAM [SKIN APEEL, INC.]	2	Current NDC, 1 package rows	20250116_c3bbe779-b012-4f19-8b90-2c7a4dd88617.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 57 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE	Old East Main Co.	db876d34-1af9-4e0a-9e9a-32a8b00e9405	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Old East Main Co.	2ea288fe-815d-4568-9592-55ea428448fa	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	cea1c223-c9d4-42ac-8c5b-c0ca647d57a1	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Old East Main Co.	00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	8f4a6a31-2fae-42fe-924f-10237c59e791	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ef48288b-533f-4924-ba12-fc8cb83643d4	2026-03-02	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	e6976bf4-ad77-4953-858f-4a0ec7f4300c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	b3d2da09-d9c9-4c27-82fe-a434ece2f099	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ba9331ef-3744-4072-80a2-af95c6f7ee05	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	1a53d8d5-e650-4825-8a3b-7cf42c36e3e5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	086dfda5-9fe7-46b4-9964-4977b86cfdd5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ce9a2139-c5c2-43e2-bd51-1f14ace594d9	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Bask SPF 40 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Surfside Skincare, Inc. dba Bask Suncare	49a30877-e39f-46a3-e063-6394a90a8dd2	2026-03-02	Warnings	Exact identifier application number: M020
Sunscreen SPF30	AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%	Worthy Promotional Products	f6014a97-12d3-4f42-86de-866a206c6c06	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30V	SPF30 BS VANILLA	Epic Laboratories, LLC	02488aad-28be-4ffb-e063-6294a90ad01e	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30T	SPF30 BS TROPICAL	Epic Laboratories, LLC	0286f94e-a2e8-b529-e063-6294a90ac08d	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30V	SPF30 BS ORIGINAL	Epic Laboratories, LLC	1872eefd-d702-ac9f-e063-6294a90a24ef	2026-03-02	Warnings	Exact identifier application number: M020
JAYSUING White Birch Moisturizing Sunscreen Cream	TITANIUM DIOXIDE	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	4c174691-cc32-b2e4-e063-6294a90a0f73	2026-03-02	Warnings	Exact identifier application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer	ZINC OXIDE	Kypris Beauty LLC	a5d5f7bd-d7bf-4a5c-8530-b9d5d74754c3	2026-02-27	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
83628-208-50	83628020850	50 g in 1 BOTTLE, PUMP (83628-208-50)	50 g	2023-09-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Skin Apeel, Inc. \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2025-01-13	HUMAN OTC DRUG LABEL	2