burnd

Product NDC: 85455-100
11-digit product format: 854550100
Labeler code: 85455
Product ID: 85455-100_4df29d85-4168-2ee1-e063-6294a90ab080
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octinoxate, Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: BURND LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-04-09
Substance: HOMOSALATE; OCTINOXATE; ZINC OXIDE
Active strength: 8; 7.5; 8.1 g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: burnd
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	8 g/100mL
OCTINOXATE	7.5 g/100mL
ZINC OXIDE	8.1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
31cf923e-fdde-790b-e063-6294a90a60ee	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85455-100-01	burnd	100 mL in 1 TUBE	LOTION	100	7
85455-100-61	burnd	7.5 mL in 1 PACKET	LOTION	7.5	7
85455-100-62	burnd	5.9 mL in 1 PACKET	LOTION	5.9	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85455-100	BURND (HOMOSALATE, OCTINOXATE, ZINC OXIDE) LOTION [2 OARS INVESTMENTS DBA BURND]	1	Current NDC, 3 package rows	20250410_31cf923e-fdde-790b-e063-6294a90a60ee.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 71 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 241	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	a100b05a-06b7-4c65-9822-3f62ca029f40	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 331	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	c3dd293c-8819-4406-af60-41b632a8c00f	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 342	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	99a92fc5-9a3e-434a-9a5b-3cc47efeea53	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 351	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e6cd9c7a-29ef-4132-a3e5-575dddb36a9e	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	ea630f2c-49a7-4900-a0ac-b0e1c554aff9	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	cc9c9b69-a0ea-44ac-a590-2cd241ce3162	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e38a10a8-73ac-4fc5-bbde-537ccb845e6f	2026-01-22	Warnings	Exact identifier application number: M020
Designer Lip Smoothie SPF 15 Lip Balm	AVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUM	Australian Gold	6fd1bd4f-ef94-42b5-a26c-2a02718c113f	2026-01-22	Warnings	Exact identifier application number: M020
Australian Gold SPF 15 Lip Balm	OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY	Australian Gold	92966c2d-b61a-4f8b-a5c1-8dfb6352c82f	2026-01-22	Warnings	Exact identifier application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50g	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE	DONGDONGGURIMOO CO.,LTD.	4907eb9c-3978-27ed-e063-6394a90a9f66	2026-01-22	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	be9f7608-cfaa-4b16-83dd-0580047af56c	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6b27df44-c441-4ae8-a1b0-a9cf2fff6f21	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3c295f6b-6202-a2e1-e063-6394a90a9a60	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	b2eee48f-b644-403c-a57e-04a1491bc386	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	ebcc2c6c-a039-48d5-8c1c-5b347254c4c2	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6967f8bc-3092-44a9-926a-6c11676425e5	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	37d4d8c1-e76b-48a3-9a13-f0543af1b28f	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	fa5046f2-a6db-4ac3-a78f-1b5df075d7e8	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	0c5fc63f-1899-4406-944a-1cdcdf8b4277	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	58a84ecd-3f27-40fc-8e0b-e29192679e6b	2026-01-21	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85455-100-01	85455010001	100 mL in 1 TUBE (85455-100-01)	100 ml	2025-04-09	No	No	Current
85455-100-61	85455010061	7.5 mL in 1 PACKET (85455-100-61)	7.5 ml	2025-04-09	No	No	Current
85455-100-62	85455010062	5.9 mL in 1 PACKET (85455-100-62)	5.9 ml	2025-04-09	No	No	Current