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 336 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1	TITANIUM DIOXIDE	Amway Corp	706e1504-fad7-44fa-9030-f5b948e3e79b	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1	TITANIUM DIOXIDE	Amway Corp	b785af89-1134-4fc6-8388-c47c52d153e0	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Natural L2N2	TITANIUM DIOXIDE	Amway Corp	db24e10a-6957-4ce7-8b03-572caacc647a	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1	TITANIUM DIOXIDE	Amway Corp	e7d8616d-3e79-4b5e-b05b-fbb506c0203d	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Plush L3C1	TITANIUM DIOXIDE	Amway Corp	ff387c87-4ada-41c6-b62b-07a143213770	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1	TITANIUM DIOXIDE	Amway Corp	48c0bb8b-2f89-465e-9ae6-98690a2f877c	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Buff L1W1	OCTINOXATE, OXYBENZONE	Amway Corp	11a8cc16-33f1-43d1-9f35-aa0f6e70adf6	2023-10-22	Warnings	Exact identifier application number: M020
CoreTex Sun X SPF 30 Thin	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE	CoreTex Products Inc	980388b5-8314-3143-e053-2995a90a7288	2023-10-22	Warnings	Exact identifier application number: M020
CoreTex Sun X SPF 30 Multipack New	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products	f4ed9d7f-2d03-87d1-e053-2a95a90a3b4f	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chablis L1C1	OCTINOXATE, OXYBENZONE	Amway Corp	8cdf7dcf-c2fa-4e41-8d56-c4f6cebe0a90	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Mink L6W1	OCTINOXATE, OXYBENZONE	Amway Corp	429044b1-f7b8-4d1e-8360-0feb380161dd	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cream L1W2	OCTINOXATE, OXYBENZONE	Amway Corp	e7e89303-f399-46c7-a029-c6d3d0a2dc4e	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Skin Nutrition BALANCING Matte Day	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Access Business Group LLC	d4a87153-7ef0-4365-ad91-dced9b1d8055	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/Medium	ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	830a748f-bb14-47f6-ab6f-48d8bd706321	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Skin Nutrition HYDRATING Day	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Access Business Group LLC	06313228-7a79-48c5-8fd0-b210da6d037b	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Access Business Group LLC	bd4818b3-d5db-4812-96ec-1bd91aa1508b	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/Deep	ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	20c432e2-4c63-485b-9dd5-2bc73b6f4285	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - Light	ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Access Business Group LLC	070f9538-4b36-471a-aa06-6669e9ecfdf0	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Medium	ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	40a82d20-b84b-4ae8-818d-1f503ceef581	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Access Business Group LLC	4a0af0e9-04da-4b5f-a57a-967bef725789	2023-10-21	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