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 312 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Tekweld Solutions, Inc.	ea9f4d57-b00c-48ce-b833-9690be98bffd	2023-12-26	Warnings	Exact identifier application number: M020
Best Skin Days BS SPF 30	ZINC OXIDE	Allure Labs	0d7072f8-e808-5270-e063-6294a90a1ffa	2023-12-26	Warnings	Exact identifier application number: M020
Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	f0d6518b-d795-4740-a301-1804a932ec45	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow	OCTINOXATE	L'Oreal USA Products Inc	4f4a8c37-af08-4bf7-89bc-1e487417c146	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow	OCTINOXATE	SICOS ET CIE	7051f505-f874-4214-ad4f-55a956cc35a7	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	08645f1d-7ba7-4410-8600-3d3f79d71385	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	fc847725-b7a9-41f1-a605-d1d892fed06f	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift Firming Face Neck For All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	df67b49c-f8b6-4c0a-9e8d-c94dee3635ff	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 Day	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	a9b7e52c-8799-49ba-8b05-7559fe6668fe	2023-12-23	Warnings	Exact identifier application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fair	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	32569352-c51e-4f05-a8b0-749ef916a5af	2023-12-22	Warnings	Exact identifier application number: M020
Circadia Circa-Shield Mineral Sunscreen SPF 30	ZINC OXIDE	Circadia by Dr Pugliese, Inc.	2959aa56-be7f-4721-9701-e6d6e12cc850	2023-12-22	Warnings	Exact identifier application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc	0adb52f5-4e1f-4570-9b6f-584e4da61d9f	2023-12-22	Warnings	Exact identifier application number: M020
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36	OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE	ESTEE LAUDER INC	c670635a-63d8-4b0b-afd7-b26e969f93a1	2023-12-21	Warnings	Exact identifier application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutral	TITANIUM DIOXIDE	Tarte, Inc.	62fffef6-29ae-4137-b0b9-fb93d6167933	2023-12-21	Warnings	Exact identifier application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutral	TITANIUM DIOXIDE	Tarte, Inc.	889860fc-7fce-47e9-af28-a3b2aec04a0e	2023-12-21	Warnings	Exact identifier application number: M020
JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Ascendant Beauty LLC	cba4e886-c4c6-4377-8f4c-250aef4b95fb	2023-12-21	Warnings	Exact identifier application number: M020
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	d12e30bd-88ee-4e34-ae63-c34766aed3a8	2023-12-20	Warnings	Exact identifier application number: M020
COOLA Liplux Hydrating Oil SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	2d2ad94c-ea13-43c0-ab7f-acecf4d2309f	2023-12-20	Warnings	Exact identifier application number: M020
Coola Bare Republic Mineral Face-Lotion SPF 70	TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%	COOLA LLC	a334a61d-5c5a-4f45-b202-6dd7bb3d250b	2023-12-20	Warnings	Exact identifier application number: M020
Bare Republic Big Adventure Stick SPF 70	TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%	COOLA	e800f72f-8c8b-4a12-843f-1ee404055cf0	2023-12-20	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