SPF 15 Protective Balm with UVA/UVB Sunscreens

Product NDC: 62499-420
11-digit product format: 624990420
Labeler code: 62499
Product ID: 62499-420_9d8f4ada-04b4-4bcb-a3b3-ab5e5ad0693f
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate Octisalate Oxybenzone
Dosage form: STICK
Route: TOPICAL
Labeler: Laboratoire Dr Renaud inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-03-21
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OXYBENZONE
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	62499-420		I	Inactivated by FDA		2026-10-15
excluded package	package	62499-420	62499-420-11	I	Inactivated by FDA		2026-10-15

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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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	62499-420-11	`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
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
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
62499-420-11	2019-10-29	C162847	48780-1	960f7f55-c884-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62499-420-02	SPF 15 Protective Balm with UVA/UVB Sunscreens	3.8 g in 1 CARTRIDGE	STICK	3.8		3
62499-420-11	SPF 15 Protective Balm with UVA/UVB Sunscreens	1 in 1 BOX	STICK	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
ACETATE ION	INACTIVE INGREDIENT	569DQM74SC	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
BETA CAROTENE	INACTIVE INGREDIENT	01YAE03M7J	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
GLYCERYL MONOOLEATE	INACTIVE INGREDIENT	4PC054V79P	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
ISOPROPYLPARABEN	INACTIVE INGREDIENT	A6EOX47QK0	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
RICINUS COMMUNIS SEED	INACTIVE INGREDIENT	7EK4SFN1TX	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
T-BUTYLHYDROQUINONE	INACTIVE INGREDIENT	C12674942B	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62499-420	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3	Legacy NDC, 2 package rows	20110330_b8f9e04b-9fe5-478a-8b39-3ff0a03a8797.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
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
62499-420-02	62499042002	3.8 g in 1 CARTRIDGE	3.8 g	Historical
62499-420-11	62499042011	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Laboratoire Dr Renaud inc. \| Laboratoire Dr Renaud inc	2011-03-23	HUMAN OTC DRUG LABEL	3