Macroantioxidant Sun Protection

Product NDC: 63730-340
11-digit product format: 637300340
Labeler code: 63730
Product ID: 63730-340_923e9252-a3b6-4d33-af6e-7fd0eb8d8395
Type: HUMAN OTC DRUG
Nonproprietary name: avobenzone, homosalate, octinoxate, octocrylene, oxybenzone
Dosage form: CREAM
Route: TOPICAL
Labeler: Natura Bisse International SA
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-02-02
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Active strength: 3 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	63730-340		D	Discontinued by firm		2026-10-05
excluded package	package	63730-340	63730-340-01	D	Discontinued by firm		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 · 42 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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`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	63730-340-01	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63730-340-01	2025-12-26	C162847	48780-1	9d75b9d0-59d7-f424-e053-dadaa90a57ce	1b27d084-d9e3-442d-80bd-cc217fd20315
63730-340-01	2020-01-31	C162847	48780-1	9d75b9d0-59d7-f424-e053-dadaa90a57ce	1b27d084-d9e3-442d-80bd-cc217fd20315

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
.ALPHA.-AMYLCINNAMALDEHYDE	INACTIVE INGREDIENT	WC51CA3418	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
7-DEHYDROCHOLESTEROL	INACTIVE INGREDIENT	BK1IU07GKF	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
BENZOTRIAZOLYL DODECYL P-CRESOL	INACTIVE INGREDIENT	298PX4M11X	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
CITRUS AURANTIUM FRUIT OIL	INACTIVE INGREDIENT	59JDQ5VT0T	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
CITRUS NOBILIS	INACTIVE INGREDIENT	8MFF77J91V	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
CITRUS SINENSIS FRUIT OIL	INACTIVE INGREDIENT	WV48LBL15Q	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
GERANIOL	INACTIVE INGREDIENT	L837108USY	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
GLYCERYL LINOLEATE	INACTIVE INGREDIENT	4763AXI84L	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
GLYCERYL LINOLENATE	INACTIVE INGREDIENT	SGB6X4G86K	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
LIMONENE, (+)-	INACTIVE INGREDIENT	GFD7C86Q1W	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
LINALOOL, (+)-	INACTIVE INGREDIENT	F4VNO44C09	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
ORYZA SATIVA WHOLE	INACTIVE INGREDIENT	84IVV0906Z	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
POLYACRYLIC ACID (250000 MW)	INACTIVE INGREDIENT	9G2MAD7J6W	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
PROPYLHEPTYL CAPRYLATE	INACTIVE INGREDIENT	991Z19V2OD	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63730-340	MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]	1	Legacy NDC	20150203_1b27d084-d9e3-442d-80bd-cc217fd20315.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
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Macroantioxidant Sun Protection - Natura Bisse International SA	Natura Bisse International SA	2015-02-02	HUMAN OTC DRUG LABEL	1