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 246 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Revlon Colorstay Liquid Makeup for Normal to Dry Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	414538d6-9108-54bf-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Preo and Protect Primer	TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMER	Revlon Consumer Products Corp	8eebf23e-7fce-dfc0-e053-2995a90ae322	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Kiss Balm SPF 20	AVOBENZONE, BENZOPHENONE-3, OCTINOXATE	Revlon Consumer Products Corp	410d1cb2-6c90-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon PhotoReady BB Cream Skin Perfector	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410ca372-4698-029d-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Liquid Makeup for Oily to Combination Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410d1cb2-6c92-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
REVLON PHOTOREADY INSTA-FIX MAKEUP	TITANIUM DIOXIDE, ZINC OXIDE	Revlon Consumer Products Corp	442f2a06-47c0-2522-e054-00144ff88e88	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Youth FX	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	442dec1e-032c-28de-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Medium	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a971e38-af63-e069-e063-6294a90a8f77	2024-12-31	Warnings	Exact identifier application number: M020
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	d9209277-469d-48f4-bf64-f39a70c19596	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Light	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a987b85-efdb-eb95-e063-6394a90aef81	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Light	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a984dd9-7293-77f0-e063-6294a90a8f1e	2024-12-31	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	097fc15e-ea17-47b2-9581-19c5e11592f6	2024-12-30	Warnings	Exact identifier application number: M020
HERBAL UV DEFENSE SPF40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	COSMAX USA, CORPORATION	2a76fd94-2f1f-e6d8-e063-6294a90a287c	2024-12-30	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	ab20969a-8640-307d-e053-2a95a90a004d	2024-12-30	Warnings	Exact identifier application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Exelencia importers Corp.	2a845e4c-86e7-1799-e063-6294a90a9b2b	2024-12-30	Warnings	Exact identifier application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15	OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENE	Revlon Consumer Products Corp	012be422-1b4c-443c-9484-02efc744296d	2024-12-30	Warnings	Exact identifier application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	REVLON	2a857553-5ad0-a0e2-e063-6294a90af435	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2035ab03-80b4-49f4-b379-eb8bc42c9cee	2024-12-30	Warnings	Exact identifier application number: M020
PRISMA PROTECT SPF30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	713bad2e-bf32-4cd5-9630-b8d88d437686	2024-12-30	Warnings	Exact identifier application number: M020
Protection 50 Sport	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	e9ace96a-7717-4f5a-8e1b-1f56f7498599	2024-12-30	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