FDA.reportPublic FDA data

Tenacious Ergodyne KREWD Clear SPF 50 Continuous Spray

Manufacturer
Tenacious Holdings, Inc.
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:29:06

Label at a glance#

ProductTenacious Ergodyne
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

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

Dosage and administration

Spray liberally and spready evenly by hand 15 minutes before sun exposure Hold can 4-6 inches away from the skin to apply Do not spray directly into face. Spray into hands then apply to face Do not apply in windy conditions Use in a well-ventilated area reapply:    • after 80 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hours children under 6 months of age: Ask a doctor...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses 

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

For external use only

FLAMMABLE:

WARNINGS AND PRECAUTIONS SECTION

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

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. • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressures. • do not store at temperatures above 120°F.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

• rash occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray liberally and spready evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into hands then apply to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area
  • reapply:

   • after 80 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

   • limit time in the sun, especially from 10 a.m.-2 p.m.

   • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73620-002-372021-10-21C16284748780-1c7ccaba7-1d79-fd44-e053-dadaa90aa01bTenacious Ergodyne KREWD Clear SPF 50 Continuous Spray
73620-002-372021-07-23C16284748780-1c7ccaba7-1d79-fd44-e053-dadaa90aa01bTenacious Ergodyne KREWD Clear SPF 50 Continuous Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73620-002-37TenaciousErgodyne156 g in 1 CANAEROSOL, SPRAY1564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73620-002TENACIOUS ERGODYNE (KREWD CLEAR SPF 50 CONTINUOUS SPRAY) AEROSOL, SPRAY [TENACIOUS HOLDINGS, INC.]4Current NDC, Legacy NDC, 1 package rows20241025_55d99d0a-dc7f-4915-b7c1-f999c8b36e0d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73620-00273620-002-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
STEAROXYTRIMETHYLSILANE9862TW94B2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Tenacious ErgodyneKREWD CLEAR SPF 50 CONTINUOUS SPRAYTenacious Holdings, Inc.55d99d0a-dc7f-4915-b7c1-f999c8b36e0d2024-10-23WarningsExact identifier
ndc (package): 73620-002-37
ndc (product): 73620-002
ndc11 (package): 73620000237
spl id: 2527d148-82dc-f995-e063-6394a90afaf9
spl set id: 55d99d0a-dc7f-4915-b7c1-f999c8b36e0d

Reported adverse events (FAERS/openFDA)#

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