STOP THE CLOCK BROAD SPECTRUM SPF 50

Product NDC: 42485-006
11-digit product format: 424850006
Labeler code: 42485
Product ID: 42485-006_3aca1373-e465-44ff-8379-0366d682e837
Type: HUMAN OTC DRUG
Nonproprietary name: avobenzone, homosalate, titanium dioxide, zinc oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Biopelle, Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-08-01
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 30 mg/mL; mg/mL; mg/mL; mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42485-006		I	Inactivated by FDA		2026-08-03
excluded package	package	42485-006	42485-006-01	I	Inactivated by FDA		2026-08-03

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 · 44 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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`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	42485-006-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42485-006-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42485-006-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42485-006-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42485-006-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42485-006-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42485-006-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42485-006-01	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42485-006-01	2019-11-13	C162847	48780-1	97449f38-c857-f6ea-e053-dbdaa90aa703	Stop the Clock Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42485-006-01	STOP THE CLOCK BROAD SPECTRUM SPF 50	50 mL in 1 JAR	CREAM	50		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
.GAMMA.-AMINOBUTYRIC ACID	INACTIVE INGREDIENT	2ACZ6IPC6I	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
ADENOSINE TRIPHOSPHATE	INACTIVE INGREDIENT	8L70Q75FXE	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
C18-36 ACID TRIGLYCERIDE	INACTIVE INGREDIENT	ZRA72DR3R7	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
CAT'S CLAW	INACTIVE INGREDIENT	9060PRM18Q	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
DIMETHICONOL (41 MPA.S)	INACTIVE INGREDIENT	343C7U75XW	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
DIPALMITOYL HYDROXYPROLINE	INACTIVE INGREDIENT	E6AHA53N1H	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
HEXANOYL DIPEPTIDE-3 NORLEUCINE ACETATE	INACTIVE INGREDIENT	P8A02Z93M6	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
N-ACETYL-TYROSINE	INACTIVE INGREDIENT	DA8G610ZO5	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
POLYISOBUTYLENE (1000 MW)	INACTIVE INGREDIENT	5XB3A63Y52	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
POLYSILICONE-15	INACTIVE INGREDIENT	F8DRP5BB29	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
PORPHYRA UMBILICALIS	INACTIVE INGREDIENT	14AN0J70WO	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
POTATO	INACTIVE INGREDIENT	CFE1S8DYWD	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
PROLINE	INACTIVE INGREDIENT	9DLQ4CIU6V	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
SODIUM LACTATE	INACTIVE INGREDIENT	TU7HW0W0QT	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
SODIUM STEAROYL GLUTAMATE	INACTIVE INGREDIENT	65A9F4P024	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42485-006	STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	1	Legacy NDC, 1 package rows	20111014_1725b5af-fe03-4372-beaf-d6fd9088a1f1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
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	Status
42485-006-01	42485000601	50 mL in 1 JAR	50 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Stop the Clock Broad Spectrum SPF 50	Biopelle, Inc. \| Biogenesis Inc.	2011-09-12	HUMAN OTC DRUG LABEL	1