OP Dark Formula Xtreme Tanning 4

Product NDC: 62802-600
11-digit product format: 628020600
Labeler code: 62802
Product ID: 62802-600_b9914b80-2352-42d3-899d-959ae2f5ef1e
Type: HUMAN OTC DRUG
Nonproprietary name: octinoxate, octisalate
Dosage form: LOTION
Route: TOPICAL
Labeler: Sun & Skin Care Research, LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-01-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE
Active strength: 3 mL/100mL; mL/100mL
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	62802-600		I	Inactivated by FDA		2026-10-05
excluded package	package	62802-600	62802-600-08	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 · 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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`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	62802-600-08	`110d247fa046…`	`a55b01930146…`

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
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62802-600-08	2019-11-13	C162847	48780-1	97449f38-d10f-f6ea-e053-dbdaa90aa703	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62802-600-08	OP Dark Formula Xtreme Tanning 4	251 mL in 1 BOTTLE	LOTION	251		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
CANOLA OIL	INACTIVE INGREDIENT	331KBJ17RK	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
POLYISOBUTYLENE (2300 MW)	INACTIVE INGREDIENT	DSQ2V1DD1K	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62802-600	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4	Legacy NDC, 1 package rows	20120522_13ecb810-e04b-4c38-bef0-e3f4f24de7be.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
62802-600-08	62802060008	251 mL in 1 BOTTLE	251 ml	Historical