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 295 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	01c9c677-9da1-47d9-8b7e-b21f8450c5c3	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	5ab9c228-28e2-43fc-8e0b-7f8e118cb388	2024-06-26	Warnings	Exact identifier application number: M020
SEAWEED BATH CO SPF 40 SPORT	AVOBENZONE, OCTISALATE, OCTOCRYLENE	The Seaweed Bath Co.	d64d4a52-0bea-4bbc-8d34-e16c1b4efe8c	2024-06-26	Warnings	Exact identifier application number: M020
SEAWEED BATH CO Everyday Mineral SPF 40	ZINC OXIDE	The Seaweed Bath Co.	8380bb3f-47d0-4675-b326-620ffb74dbdf	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	be2a83fb-e4f8-4313-b5bd-150f351fb345	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	60689efb-2dd4-4322-a621-54eb2c3c3dc2	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	d8449209-65d0-43c6-8750-0f460a950157	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	066a0951-2e7e-40c0-8035-4d708a32f16c	2024-06-26	Warnings	Exact identifier application number: M020
GUIDANCE TO GLOW TRU SPF 35	ZINC OXIDE	GUIDANCE TO GLOW SKIN CARE	21b4747b-b173-43c9-b0d4-1dbba5775ff8	2024-06-25	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1bbd14ec-4240-f0c2-e063-6394a90a2c07	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	0200a00f-2b57-454d-933d-a7d48644be6e	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen	ENSULIZOLE	L'Oreal USA Products Inc	8e48e675-0b4f-4b91-85de-c4e29be65147	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	427a21cc-a668-4af8-94cb-b981d5c1919f	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	451e50a2-2dd7-4c90-88c9-b9f9056d7ee3	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen	ENSULIZOLE	SICOS ET CIE	979db22b-97eb-4818-aa01-1288b56e38b5	2024-06-25	Warnings	Exact identifier application number: M020
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant	ZINC OXIDE	SQWEEN LLC	b5bf1c4c-7c48-423c-b4fc-52ae57f339fd	2024-06-24	Warnings	Exact identifier application number: M020
BANANA BOAT	ZINC OXIDE	Edgewell Personal Care Brands LLC	1ba50f16-4b76-825f-e063-6294a90a2a4d	2024-06-24	Warnings	Exact identifier application number: M020
BANANA BOAT	ZINC OXIDE	Edgewell Personal Care Brands LLC	1ba57692-c36d-ef4a-e063-6394a90a1236	2024-06-24	Warnings	Exact identifier application number: M020
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	66a91768-6012-485a-b569-a293ea6d4880	2024-06-24	Warnings	Exact identifier application number: M020
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	43539766-2e70-4b42-b64b-1d30367b2eb9	2024-06-24	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