FDA.reportPublic FDA data

Vacation Instant Browning

Product NDC
80641-521
11-digit product format
806410521
Labeler code
80641
Product ID
80641-521_31f5a47a-94b3-282a-e063-6294a90a29fe
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Octisalate Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-06
Substance
AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
2.9; 9.5; 4.9 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Instant Browning
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.9 g/100mL
OCTOCRYLENE9.5 g/100mL
OCTISALATE4.9 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13028f61-3f62-22cc-e063-6394a90a6bf1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-521-10Vacation Instant Browning148 mL in 1 BOTTLELOTION1482
80641-521-80Vacation Instant Browning30 mL in 1 BOTTLELOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-521VACATION INSTANT BROWNING (AVOBENZONE OCTISALATE OCTOCRYLENE) LOTION [VACATION INC.]2Current NDC, 2 package rows20250406_13028f61-3f62-22cc-e063-6394a90a6bf1.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 180 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premium Moisturizing Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4346f7a-3642-05d8-e053-2a95a90a013d2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4206dad-6a17-2f56-e053-2a95a90a69dc2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf434089c-126f-441c-e053-2995a90ab0c72025-10-09WarningsExact identifier
application number: M020
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)ZINC OXIDENapoleon PerdisCosmetic Pty Ltdbe64bb40-b1a9-2308-e053-2a95a90a69c82025-10-09WarningsExact identifier
application number: M020
Organys Open Formula SheerZINC OXIDEOrganys Beauty0b3ab551-cb66-cf86-e063-6394a90a7ab42025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
application number: M020
Organys Derma Made SheerZINC OXIDEOrganys Beauty0b39f550-bd34-509d-e063-6294a90a51d02025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty0b37a73b-73ca-501f-e063-6294a90a62912025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 3)ZINC OXIDEResette, Incdc89ab76-da32-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 4)ZINC OXIDEResette, Incdc89ab0b-d53e-983f-e053-2a95a90a127f2025-10-09WarningsExact identifier
application number: M020
Petroleum-Free Lip BalmOCTINOXATE AND OXYBENZONEMedline Industries, LP6125d98a-6fc7-4f50-924e-3b1f7ee951f42025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 1)ZINC OXIDEResette, Incdc89429a-022c-dd10-e053-2a95a90ac26a2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 2)ZINC OXIDEResette, Incdc89ab76-da2f-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Dr Lift SPF 50 Clear StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESpa de Soleil40c11b19-fc91-2033-e063-6394a90a5a5f2025-10-09WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Mineral BabyZINC OXIDEBlack Girl Sunscreen302bccc6-7bf3-cc69-e063-6294a90a625c2025-10-09WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0436b-85b6-5099-e063-6294a90a4c2e2025-10-09WarningsExact identifier
application number: M020
CoreTex Professional Outdoor Skin Protection WalletCORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLETCoreTex Products Incf57bc089-405b-cdcd-e053-2995a90a9d122025-10-09WarningsExact identifier
application number: M020
Mist Me SPF-40ZINC OXIDECove Suncare LLCb7f09089-54a4-4f60-b632-e3f4321313ec2025-10-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-521-1080641052110148 mL in 1 BOTTLE (80641-521-10) 148 ml2024-03-06NoNoCurrent
80641-521-808064105218030 mL in 1 BOTTLE (80641-521-80) 30 ml2024-03-06NoNoCurrent