VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

Product NDC: 80641-001
11-digit product format: 806410001
Labeler code: 80641
Product ID: 80641-001_47224083-a029-4253-9660-b228c66263ff
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: Vacation Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-15
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 25; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	25 mg/mL
HOMOSALATE	100 mg/mL
OCTISALATE	50 mg/mL
OCTOCRYLENE	80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	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
c7794831-52d1-4d80-936d-44af18ae0472	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
80641-001-01	2024-03-04	VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-02	2024-03-04	VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-03	2024-03-04	VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-01	2024-01-30	VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-02	2024-01-30	VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-03	2024-01-30	VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80641-001-01	VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	100 mL in 1 TUBE	LOTION	100	8
80641-001-02	VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	30 mL in 1 TUBE	LOTION	30	8
80641-001-03	VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	7 mL in 1 PACKET	LOTION	7	8
80641-001-04	VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	177 mL in 1 TUBE	LOTION	177	8
80641-001-04	VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	2 in 1 KIT	LOTION	2	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80641-001	VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [VACATION INC.]	5	Current NDC, Legacy NDC, 5 package rows	20250109_c7794831-52d1-4d80-936d-44af18ae0472.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 266 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MISSHA M Perfect Cover BB No 21	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	9585d3d2-806c-36e3-e053-2a95a90a28fa	2024-12-04	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB SPF42 No21	OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	3d196cf3-eddd-21d7-e054-00144ff88e88	2024-12-04	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 23	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	6a81522e-f4d9-4013-8563-f50f01ff6326	2024-12-04	Warnings	Exact identifier application number: M020
Milani Prime Protect SPF 30 Face Primer	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	The Milani Group, Inc.	d557d554-5161-482c-bd78-7721c7dc9a6e	2024-12-04	Warnings	Exact identifier application number: M020
Pipette Diaper Rash	ZINC OXIDE	Amyris, Inc	ef5ea6f5-0126-47de-9bee-9070c5f6112b	2024-12-04	Warnings	Exact identifier application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50	ZINC OXIDE	CP Skin Health Group, Inc	81a889b8-0719-40c9-b8d4-d9220747ce49	2024-12-04	Warnings	Exact identifier application number: M020
Bright-eyed 100% mineral Eye Cream Broad Spectrum Sunscreen SPF 40	ZINC OXIDE	Supergoop, LLC	971ac413-5e69-7553-e053-2995a90a4168	2024-12-04	Warnings	Exact identifier application number: M020
PLAY Antioxidant Body Mist SPF 50 With Vitamin C	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	9c5c0608-3f42-6640-e053-2a95a90a5086	2024-12-04	Warnings	Exact identifier application number: M020
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100	TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S A	e4bb5a32-c5dc-86d5-e053-2a95a90a4938	2024-12-04	Warnings	Exact identifier application number: M020
Burts Bees Firming Day SPF30	ZINC OXIDE	Burts Bees	f028ffea-184b-46db-9e48-dab4a535bf00	2024-12-03	Warnings	Exact identifier application number: M020
Burts Bees Calming Day SPF30	ZINC OXIDE	Burts Bees	e406e6ba-fa6d-452d-bc29-404e2f8fcf3e	2024-12-03	Warnings	Exact identifier application number: M020
BaliBody SPF15 Bronze Shimmering Tanning Gel	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	28660ce2-6805-41f3-e063-6394a90af45d	2024-12-03	Warnings	Exact identifier application number: M020
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber	ZINC OXIDE, TITANIUM DIOXIDE	Alumier Labs	ba864a08-e66d-d286-e053-2995a90a1854	2024-12-03	Warnings	Exact identifier application number: M020
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	2874e531-d647-339c-e063-6394a90ac86f	2024-12-03	Warnings	Exact identifier application number: M020
REEF SAFE Unscented SPF Mineral Sunscreen 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	286965aa-0961-0141-e063-6394a90aa3f0	2024-12-03	Warnings	Exact identifier application number: M020
Alumier MD Sheer Hydration Tinted Moisturizing Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a951ebe7-7786-38ef-e053-2995a90a70e3	2024-12-03	Warnings	Exact identifier application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Expanscience Laboratories d/b/a Mustela	beec926c-35a5-1901-e053-2a95a90ad043	2024-12-02	Warnings	Exact identifier application number: M020
MUSTELA MINERAL SUNSCREEN SPF 50	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	b850f68e-4f52-6902-e053-2995a90aaa91	2024-12-02	Warnings	Exact identifier application number: M020
Hero Force Shield Superbeam Sunscreen SPF 30 Apricot	ZINC OXIDE	Church & Dwight Co., Inc.	133dc4db-6598-4400-8aa4-022f66eb28fc	2024-12-02	Warnings	Exact identifier application number: M020
AHAVA MultiVitamin Day SPF30	AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	d9b8e9ae-ed05-4e9c-8d01-8fac183053a4	2024-12-02	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
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
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
80641-001-01	80641000101	100 mL in 1 TUBE (80641-001-01)	100 ml	2022-04-06	0000-00-00	No	No	Current
80641-001-02	80641000102	30 mL in 1 TUBE (80641-001-02)	30 ml	2022-04-06	0000-00-00	No	No	Current
80641-001-03	80641000103	7 mL in 1 PACKET (80641-001-03)	7 ml	2022-04-06	0000-00-00	No	No	Current
80641-001-04	80641000104	2 TUBE in 1 KIT (80641-001-04) / 177 mL in 1 TUBE	2 tube	2024-03-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	Vacation Inc.	2026-03-20	HUMAN OTC DRUG LABEL	8