Tinted SPF 45

Product NDC: 10477-2627
11-digit product format: 104772627
Labeler code: 10477
Product ID: 10477-2627_cfc06532-2c88-4de7-9c63-2cbba8f59817
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octisalate, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Goodier Cosmetics, LP
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2007-12-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength: 8 g/100g; g/100g; g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10477-2627		I	Inactivated by FDA	2026-10-21
excluded package	package	10477-2627	10477-2627-1	I	Inactivated by FDA	2026-10-21
excluded package	package	10477-2627	10477-2627-2	I	Inactivated by FDA	2026-10-21
excluded package	package	10477-2627	10477-2627-3	I	Inactivated by FDA	2026-10-21

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10477-2627-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10477-2627-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10477-2627-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10477-2627-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10477-2627-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10477-2627-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10477-2627-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10477-2627-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10477-2627-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10477-2627-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10477-2627-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10477-2627-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10477-2627-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10477-2627-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10477-2627-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10477-2627-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10477-2627-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10477-2627-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10477-2627-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10477-2627-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10477-2627-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10477-2627-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10477-2627-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10477-2627-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10477-2627-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10477-2627-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10477-2627-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10477-2627-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10477-2627-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10477-2627-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10477-2627-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10477-2627-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10477-2627-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10477-2627-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10477-2627-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10477-2627-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10477-2627-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10477-2627-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10477-2627-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10477-2627-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10477-2627-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10477-2627-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10477-2627-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10477-2627-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10477-2627-1	`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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10477-2627-1	2019-11-13	C162847	48780-1	97449f38-c94d-f6ea-e053-dbdaa90aa703	6b68c45a-8685-4166-8628-2d304048251c
10477-2627-2	2019-11-13	C162847	48780-1	97449f38-c94d-f6ea-e053-dbdaa90aa703	6b68c45a-8685-4166-8628-2d304048251c
10477-2627-3	2019-11-13	C162847	48780-1	97449f38-c94d-f6ea-e053-dbdaa90aa703	6b68c45a-8685-4166-8628-2d304048251c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10477-2627-1	Tinted SPF 45	1 in 1 CARTON	CREAM	1	1
10477-2627-1	Tinted SPF 45	48 g in 1 TUBE	CREAM	48	1
10477-2627-2	Tinted SPF 45	227 g in 1 TUBE	CREAM	227	1
10477-2627-3	Tinted SPF 45	3 g in 1 TUBE	CREAM	3	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
BETULA PUBESCENS BARK	INACTIVE INGREDIENT	3R504894L9	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)	INACTIVE INGREDIENT	V2W71V8T0X	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
ETHYLHEXYL STEARATE	INACTIVE INGREDIENT	EG3PA2K3K5	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
PALMITOYL TRIPEPTIDE-5	INACTIVE INGREDIENT	2A3916MQHO	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
UBIDECARENONE	INACTIVE INGREDIENT	EJ27X76M46	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10477-2627	TINTED SPF 45 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GOODIER COSMETICS, LP]	1	Legacy NDC, 4 package rows	20111206_6b68c45a-8685-4166-8628-2d304048251c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
10477-2627-1	10477262701	1 in 1 CARTON		Historical
10477-2627-2	10477262702	227 g in 1 TUBE	227 g	Historical
10477-2627-3	10477262703	3 g in 1 TUBE	3 g	Historical