TANCEUTICALS SPF DROPS Broad Spectrum SPF-30

Manufacturer
TANCEUTICALS, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:10

Label at a glance#

ProductTANCEUTICALS SPF DROPS Broad Spectrum SPF-30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection  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

Dosage and administration

Apply liberally 15 minutes before sun exposure or as needed  Reapply:After swimming or sweating, immediately after towel drying, at least every 2 hours Spending time in the sun increases your risk of skin cancer and early sking aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including: Sun Protection Measures. Limit time in the sun, espe...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%, Homosalate 10.00%,

Octisalate 5.00%, Octocrylene 6.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection 
  • 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

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure or as needed 
  • Reapply:After swimming or sweating, immediately after towel drying, at least every 2 hours
  • Spending time in the sun increases your risk of skin cancer and early sking aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

  • Prorect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Matricaria (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocamidopropyl Betaine, Daucus Carota Sativa (Carrot) Extract, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrogenated Methyl Abietate, Isopropyl Myristate, Mangifera Indica (Mango) Butter, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Phenyl Trimethicone, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Sodium Benzoate, Sodium Hyaluronate, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E).

Questions?

OTC - QUESTIONS SECTION

Call us at 800-994-3752

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82675-279-00TANCEUTICALS SPF DROPS Broad Spectrum SPF-301 in 1 BOXSOLUTION12
82675-279-00TANCEUTICALS SPF DROPS Broad Spectrum SPF-3030 mL in 1 BOTTLE, PUMPSOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82675-279TANCEUTICALS SPF DROPS BROAD SPECTRUM SPF-30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SOLUTION [TANCEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20231112_8640b971-7c99-4c8f-ac5c-ecdd88b99fe0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82675-27982675-279-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETANCEUTICALS, LLC8640b971-7c99-4c8f-ac5c-ecdd88b99fe02023-11-11WarningsExact identifier
ndc (package): 82675-279-00
ndc (product): 82675-279
ndc11 (package): 82675027900
spl id: 09e35e72-c03d-4d9a-e063-6294a90acdd1
spl set id: 8640b971-7c99-4c8f-ac5c-ecdd88b99fe0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.