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 345 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
H.E.B Solutions Sunscreen	COCONUT PINEAPPLE SCENTED SPF 50 STICK	H.E.B	29aef42c-f617-4c56-a166-8e1f0d6dbfd0	2021-07-09	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	58465981-e84c-4eaf-b7d5-fad1666f63fc	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Bamboo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	b2259b27-e1a5-482c-8916-356c1ee9774a	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Bronze	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	199dde64-1dd3-4eb6-baef-261c97162f79	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Creme	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	753c34f2-3cb8-4df7-9aeb-ea926fb0279a	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Dune	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	745dd675-86ee-4acc-8333-4870e0a57c75	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	FACE SPF 70 LOTION	H.E.B	73b49068-953b-496d-8ea9-404df7e79089	2021-01-19	Warnings	Exact identifier application number: M020
Think Every Day Face Sunscreen SPF 30	ZINC OXIDE	thinkOperations,LLC	afed91dd-8544-4b4b-e053-2995a90a2d16	2020-09-22	Warnings	Exact identifier application number: M020
THINKSPORT Kids sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	8b5a147d-4126-4fc5-a73b-fd5a19ccfd3d	2020-09-08	Warnings	Exact identifier application number: M020
THINKBABY Baby Sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	820317d2-1803-4949-bddf-09521a5d1750	2020-09-08	Warnings	Exact identifier application number: M020
THINKSPORT sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	6b9b3ea2-65e5-4a51-a6e6-c79f89e5ccea	2020-08-03	Warnings	Exact identifier application number: M020
ESSENTIALS Face and Body Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	dfc44a01-e8fd-43fc-b3cd-5cac17e4a5a3	2020-04-02	Warnings	Exact identifier application number: M020
Thinksport Sunscreen SPF 18	ZINC OXIDE	thinkOperations,LLC	9cd5010c-0b23-2888-e053-2995a90adb72	2020-01-23	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