All Physical Sunscreen Broad Spectrum SPF 50

Product NDC: 10477-1003
Requested package NDC: 10477-1003-2
11-digit product format: 104771003
Labeler code: 10477
Product ID: 10477-1003_ce68a373-4b7b-7e5c-e053-2995a90a4df9
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Goodier Cosmetics LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-03-05
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 4 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10477-1003	10477-1003-2	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10477-1003-1	2023-01-30	C162847	48780-1	f386c64a-3c5a-0266-e053-dadaa90a7c1a	All Physical Sunscreen
10477-1003-2	2023-01-30	C162847	48780-1	f386c64a-3c5a-0266-e053-dadaa90a7c1a	All Physical Sunscreen
10477-1003-3	2023-01-30	C162847	48780-1	f386c64a-3c5a-0266-e053-dadaa90a7c1a	All Physical Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10477-1003-1	All Physical Sunscreen Broad Spectrum SPF 50	48 g in 1 TUBE	LOTION	48	2
10477-1003-1	All Physical Sunscreen Broad Spectrum SPF 50	1 in 1 CARTON	LOTION	1	2
10477-1003-2	All Physical Sunscreen Broad Spectrum SPF 50	227 g in 1 TUBE	LOTION	227	2
10477-1003-3	All Physical Sunscreen Broad Spectrum SPF 50	3 g in 1 TUBE	LOTION	3	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10477-1003	ALL PHYSICAL SUNSCREEN BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [GOODIER COSMETICS LLC]	2	Legacy NDC, 4 package rows	20211020_f7e8fa24-aff9-4e10-9654-f738a6490660.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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	Marketing end	Sample	Exclude flag	Status
10477-1003-2	10477100302	227 g in 1 TUBE (10477-1003-2)	227 g	2018-03-05	0000-00-00	No	No	Current