Indications and uses
Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Drops
- Manufacturer
- Vacation Inc.
- Effective date
- 2025-02-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:55:38
Label at a glance#
ProductDrops
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 sections
Dosage and administration
Shake well Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating
Label contents#
Full prescribing information#
Dosage and administration
Shake well
Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Warning
For external use only
Do not use on damaged or broken skin
When using this product, keep out of eyes. Rinsed with water to remove.
Stop use and ask a doctor is rash occurs
Inactives
Butyloctyl Salicylate, C13-14 Alkane, Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Caprylyl Glycol, Carbomer, Cellulose Gum, Ceramide AP, Ceramide EOP, Ceramide NP, Cetearyl Alcohol, Chlorella Vulgaris Extract, Cholesterol, Coco-Glucoside, Coffea Arabica (Coffee) Seed Extract , Corylus Avellana (Hazel) Seed Oil, Ethyl Ferulate, Ferulic Acid, Fragrance, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Iron Oxides, Mica, Microcrystalline Cellulose, Niacinamide
Octyldodecyl Oleate, Phytosphingosine, Propanediol, Sodium Benzoate, Sodium Gluconate, Sodium Lauroyl Lactylate
Sodium Stearoyl Glutamate, sr-Hydrozoan Polypeptide-1, Theobroma Cacao (Cocoa) Extract, Titanium Dioxide, Tocopherol, Tridecane
Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Undecane, Water, Xanthan Gum
Indications and Usage
Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Keep out of reach of children
Keep out of reach of children
Purpose
Sunscreen
Vacation Studio Tone Bronzing Drops
Kit
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80641-013-01 | Drops | 1 in 1 KIT | LIQUID | 1 | 4 | |
| 80641-013-80 | Drops | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 4 | |
| 80641-013-94 | Drops | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Drops
- Avobenzone Octisalate Octocrylene
- BUTYLOCTYL SALICYLATE
- AVOBENZONE
- OCTISALATE
- OCTOCRYLENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80641-013 | 80641-013-94, 80641-013-01, 80641-013-80 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BUTYLOCTYL SALICYLATE | 2EH13UN8D3 | IACT |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Drops | AVOBENZONE OCTISALATE OCTOCRYLENE | Vacation Inc. | 1319d6ea-a580-79c5-e063-6394a90a4dca | 2025-02-20 | Warnings | 80641-013-01 80641-013-80 80641-013-94 80641-013 80641001380 80641001394 80641001301 2e99f7af-047a-769c-e063-6394a90a1406 1319d6ea-a580-79c5-e063-6394a90a4dca |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.