Breath Fresh SPF 15 Broad Spectrum Lip Balm

Product NDC: 65692-0516
11-digit product format: 656920516
Labeler code: 65692
Product ID: 65692-0516_0863a4d3-32aa-730f-e063-6394a90a43f2
Type: HUMAN OTC DRUG
Nonproprietary name: Breath Fresh SPF 15 Broad Spectrum Lip Balm
Dosage form: STICK
Route: TOPICAL
Labeler: Raining Rose, Inc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-02-17
Substance: AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength: .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	65692-0516		D	Discontinued by firm		2026-08-10
excluded package	package	65692-0516	65692-0516-1	D	Discontinued by firm		2026-08-10

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 · 24 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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`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	65692-0516-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Breath Fresh SPF 15 Broad Spectrum Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	.09 g/4.25g
AVOBENZONE	.28 g/4.25g
OCTOCRYLENE	.21 g/4.25g
OCTINOXATE	.06 g/4.25g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
4Y5P7MUD51	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
a0c3a62f-5c11-c78c-e053-2a95a90a3a58	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65692-0516-1	Breath Fresh SPF 15 Broad Spectrum Lip Balm	4.25 g in 1 TUBE	STICK	4.25		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65692-0516	BREATH FRESH SPF 15 BROAD SPECTRUM LIP BALM STICK [RAINING ROSE, INC]	3	Current NDC, Legacy NDC, 1 package rows	20231024_a0c3a62f-5c11-c78c-e053-2a95a90a3a58.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 1 of 360 · 7,197 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UV Skin Recovery SPF 50	ZINC OXIDE	CP Skin Health Group, Inc.	26d2683f-cfd5-50fd-e063-6394a90a7576	2026-08-06	Warnings	Exact identifier application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATE	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	58636012-7e29-7206-e063-6394a90a83e9	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
UV Skin Recovery SPF 50 Red Correcting	ZINC OXIDE	CP Skin Health Group, Inc.	26e63890-d1af-d171-e063-6394a90af828	2026-08-06	Warnings	Exact identifier application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATE	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5864275d-a480-06f8-e063-6394a90aecab	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5864881c-c495-1f32-e063-6294a90a1304	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40	ZINC OXIDE	CP Skin Health Group, Inc	945538b5-5745-42cf-b610-0018ca2ec254	2026-08-06	Warnings	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	58653d79-8fff-f319-e063-6294a90af7a3	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5865f0e5-14b2-c4bf-e063-6294a90a4710	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
EltaMD UV Restore	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	37fee381-ce6b-4949-9a4a-778aa839fb84	2026-08-06	Warnings	Exact identifier application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Kenvue Brands LLC	129ae274-0094-be5e-e063-6394a90a9801	2026-08-05	Warnings	Exact identifier application number: M020
HERA UV PROTECTOR INVISIBLE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	OTCM	584c371c-24e3-5f9c-e063-6294a90a01bc	2026-08-05	Warnings	Exact identifier application number: M020
Leader Kids Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH 110, LLC. DBA LEADER	3636693a-ba81-5d49-e063-6394a90a3006	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Ivory	CEILE TINT PROTECT TINTED SERUM SPF 50 IVORY	LE COSMETICS INC	58547809-3480-1032-e063-6294a90a04c6	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Deep	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEP	LE COSMETICS INC	58549160-3594-9056-e063-6394a90abf7d	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Deep	CEILE TINT PROTECT TINTED SERUM SPF 50 DEEP	LE COSMETICS INC	585498d4-b29c-9580-e063-6394a90adf1e	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Fair	CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR	LE COSMETICS INC	58545633-cb36-6611-e063-6394a90a1f07	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT	LE COSMETICS INC	5853ae6b-0eaf-e614-e063-6394a90ae91a	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM	LE COSMETICS INC	585473c3-3ee9-7d84-e063-6394a90abd33	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM	LE COSMETICS INC	58547b48-251a-10eb-e063-6294a90ac95c	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Tan	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN	LE COSMETICS INC	58547e38-ae84-82ee-e063-6394a90a27d6	2026-08-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65692-0516-1	65692051601	4.25 g in 1 TUBE (65692-0516-1)	4.25 g	2020-02-17	0000-00-00	No	No	Current