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 32 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Frase Skin SPF 30 Face Sunscreen Activated Vitamin D Technology	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Frase Skin PTY LTD	d904fd23-a3a1-4564-8eec-13a4c96e23f7	2026-05-12	Warnings	Exact identifier application number: M020
Hawaii Sol Natural Non-Nano Sunscreen SPF 50	ZINC OXIDE	Caribbean Sol International, LLC	24678326-547f-427d-a481-d8c40380e30a	2026-05-12	Warnings	Exact identifier application number: M020
Caribbean Sol Natural Non-Nano Sunscreen SPF 50	ZINC OXIDE	Caribbean Sol International, LLC	20aadcf6-16a3-4344-837b-b91ba8753fb0	2026-05-12	Warnings	Exact identifier application number: M020
Cancer Council Daily Face Moisturizer SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	1b4333b8-5747-c591-e063-6294a90a9924	2026-05-12	Warnings	Exact identifier application number: M020
Lather Daily Defense Mineral SPF 45 Facial Sunscreen	ZINC OXIDE	Lather, Inc.	50c732a0-b282-d61b-e063-6294a90aa76b	2026-05-12	Warnings	Exact identifier application number: M020
Hampton Sun SPF50 Mineral Face Sunscreen	HOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%	S&C Hampton Sun LLC	f1c5310b-c43b-475d-8a50-d55759ad3164	2026-05-12	Warnings	Exact identifier application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	aedde765-931f-430e-9fc3-d87bde2b78cd	2026-05-12	Warnings	Exact identifier application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	417305d7-d32e-4bc9-8f77-0a42b6bdecf5	2026-05-12	Warnings	Exact identifier application number: M020
Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Stellar Beauty Co.	0f7ee8c6-3af2-42a2-b341-3e0da42c7c93	2026-05-11	Warnings	Exact identifier application number: M020
Frase Skin SPF 50 Activated Vitamin D Technology Cool	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Frase Skin PTY LTD	0a5cc927-0fd3-4c8f-b847-a274f6eb09fb	2026-05-11	Warnings	Exact identifier application number: M020
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen	ZINC OXIDE	Miami Beach Bum	3b778530-9af0-48eb-bd91-d9ac99f2983f	2026-05-11	Warnings	Exact identifier application number: M020
Walgreens SPF 60 Melt-in Milk Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walgreens	345955ea-f37a-8629-e063-6294a90aa7cc	2026-05-11	Warnings	Exact identifier application number: M020
DERMATONE SPF50 Sunscreen	AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%	Dermatone Labs LLC	4dc81593-4790-403f-9d49-6569bcd0fea2	2026-05-11	Warnings	Exact identifier application number: M020
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Bella Medical Products LLC	518f69fc-fd39-8195-e063-6294a90a3fdd	2026-05-11	Warnings	Exact identifier application number: M020
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral Sunscreen	RADICAL RESCUE SPF 30 MINERAL SUNSCREEN	ProTransit, Inc.	38e0139c-bb87-55ba-e063-6294a90a82ee	2026-05-11	Warnings	Exact identifier application number: M020
ChapStick Moisturizer Original SPF 15	SPF 15 SKIN PROTECTANT	Suave Brands Co., LLC	47bfa8ea-4d8d-cd13-e063-6394a90a71aa	2026-05-11	Warnings	Exact identifier application number: M020
EELHOE Sunscreen	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5196ccb0-4515-7e40-e063-6394a90a09bd	2026-05-11	Warnings	Exact identifier application number: M020
Mediheal Madecassoside Moisture Sun Serum	HOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE	74005	47c66535-8287-9b74-e063-6394a90ac3b6	2026-05-10	Warnings	Exact identifier application number: M020
SPF 30 Sunscreen	HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%	Coconut Caliente Costa Rica LLC	af56f16a-2643-4bfc-9e05-dfba79cdab8a	2026-05-08	Warnings	Exact identifier application number: M020
Iris and Romeo Weekend Skin Cool Glow	ZINC OXIDE	Iris and Romeo	514f7d70-7b8b-0992-e063-6394a90a1e98	2026-05-08	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