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 284 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Safeway Signature Care Dry Touch Sunscreen SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Safeway, Inc.	c6267a29-46a5-5f38-e053-2a95a90a0117	2024-10-14	Warnings	Exact identifier application number: M020
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30	ZINC OXIDE	Safeway, Inc.	dbeff8e8-250d-8274-e053-2995a90a984e	2024-10-14	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, ZINC OXIDE	Rare Beauty, LLC	2460281d-d433-0216-e063-6394a90a9d48	2024-10-13	Warnings	Exact identifier application number: M020
Walgreens 50 Coconut Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436987c-2afe-06b5-e063-6394a90aceba	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Banana Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436bd19-2299-6e89-e063-6394a90acd99	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Clear Complexion Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f07238df-4970-7759-e053-2a95a90a39f9	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 70 Sport Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	WALGREEN COMPANY	e7165b39-54f9-4af6-e053-2a95a90af664	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MIST	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f14bb3b4-1dce-06b9-e053-2995a90a8bc8	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Sport	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f12c9767-7cb7-12c8-e053-2995a90a17be	2024-10-11	Warnings	Exact identifier application number: M020
Sulwhasoo UV Daily Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM	Amorepacific Corporation	e00451d5-8433-c4e8-e053-2a95a90a6244	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Sport Continuous Sunscreen	AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f13ec3da-2dc2-04f7-e053-2995a90a198d	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Hydrating	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f4155692-16a7-11e8-e053-2995a90abd34	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f906792b-083e-13e2-e053-6294a90ab4cf	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	WALGREEN COMPANY	f9c81d88-8e28-fa53-e053-6394a90ac5c4	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa18067a-310b-bdc3-e053-6394a90aee79	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	24223fbf-8ce9-ec5e-e063-6294a90a29da	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	2422b327-ea83-f4c3-e063-6394a90a5c6e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Watermelon Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24256e54-ae34-91b2-e063-6394a90a33c0	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Premium Face Moisturizing Sunscreen	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24265a48-fd07-c78a-e063-6394a90ab67e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2410df0a-db52-0769-e063-6394a90a52f3	2024-10-09	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