Advanced Formula Lip Balm SPF 25

Product NDC: 80949-002
11-digit product format: 809490002
Labeler code: 80949
Product ID: 80949-002_4d248a7a-9dcc-8e9f-e063-6294a90aa703
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octinoxate
Dosage form: CREAM
Route: TOPICAL
Labeler: Anthony Skin LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-05
Substance: AVOBENZONE; OCTINOXATE
Active strength: 3; 7.5 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	80949-002		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80949-002	80949-002-07	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: Advanced Formula Lip Balm SPF 25
Brand name suffix: Blood Orange
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	3 g/100g
OCTINOXATE	7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	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
74853b40-a773-4488-98a9-c8029ad21134	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80949-002-07	Advanced Formula Lip Balm SPF 25Blood Orange	7 g in 1 TUBE	CREAM	7		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80949-002	ADVANCED FORMULA LIP BALM SPF 25 BLOOD ORANGE (AVOBENZONE, OCTINOXATE) CREAM [ANTHONY SKIN LLC]	2	Current NDC, 1 package rows	20250116_74853b40-a773-4488-98a9-c8029ad21134.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 304 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BB Tint 30 BS SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	1212448c-db88-26e6-e063-6294a90a3b9e	2024-02-23	Warnings	Exact identifier application number: M020
Daily Prevention Pure Mineral Hydrating Moisturizer SPF30	ZINC OXIDE	Allure Labs	11fce5ec-66e8-9eac-e063-6394a90aaf3a	2024-02-22	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEP	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	bf31d19d-9520-4ac0-a4fd-2c285545f1b8	2024-02-20	Warnings	Exact identifier application number: M020
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	2c0964cd-607c-4219-b66e-cc99ada80434	2024-02-20	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHT	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	6259442e-0c39-4887-8083-89253b64b5ff	2024-02-20	Warnings	Exact identifier application number: M020
Meijer SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCSTISALATE 5%, OCTOCRYLENE 6%	Meijer	074b6340-0482-ab05-e063-6294a90adedb	2024-02-19	Warnings	Exact identifier application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	11c37acc-abb8-8c38-e063-6294a90a7932	2024-02-19	Warnings	Exact identifier application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	11c461f7-0f34-65ff-e063-6294a90a3da7	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	11c61b92-89f4-692f-e063-6394a90a69cd	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11c651e2-072e-770e-e063-6394a90ad6fa	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	11c65e7f-fe11-8115-e063-6394a90a8594	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11c6cf95-8923-af79-e063-6294a90a4f44	2024-02-19	Warnings	Exact identifier application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	118842ce-9d9b-80ce-e063-6394a90ab986	2024-02-16	Warnings	Exact identifier application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11894c1d-c199-dfc0-e063-6394a90a3f15	2024-02-16	Warnings	Exact identifier application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	711aa92c-81b0-42e4-b83f-9ce95116ec03	2024-02-16	Warnings	Exact identifier application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b8bc0021-bb4d-45f2-a570-3f2e61edf21d	2024-02-16	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Meijer	075dddd5-46ea-282a-e063-6294a90a28fd	2024-02-15	Warnings	Exact identifier application number: M020
Sheet SPF 30 Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Vivier Pharma Inc.	bbb5b87c-d641-3ba2-e053-2a95a90a0f70	2024-02-14	Warnings	Exact identifier application number: M020
sheer tint SPF 45	BROAD SPECTRUM	CP Skin Health Group, Inc.	b7c5cedd-ff68-74de-e053-2a95a90a3796	2024-02-14	Warnings	Exact identifier application number: M020
Weightless Protection SPF 45	SUNSCREEN BROAD SPECTRUM	CP Skin Health Group, Inc.	b6bee26d-bffd-a8ee-e053-2a95a90affc5	2024-02-14	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80949-002-07	80949000207	7 g in 1 TUBE (80949-002-07)	7 g	2020-01-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Advanced Formula Lip Balm SPF 25	Anthony Skin LLC \| Fragrance Manufacturing, Inc.	2026-03-16	HUMAN OTC DRUG LABEL	3