FDA.reportPublic FDA data

Tattoo Color Guard SPF 15 Spray

Manufacturer
Prime Enterprises Inc.
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:10:37

Label at a glance#

ProductTattoo Color Guard SPF 15
Active ingredientENSULIZOLE
Label structure9 sections

Indications and uses

helps prevent sunburn.

Dosage and administration

Spray liberally 15 minutes before sun exposure. Shake well before use Spray on tattoo artwork exposed to the elements use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ensulizole 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn.

WARNINGS SECTION

Skin cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray liberally 15 minutes before sun exposure.
  • Shake well before use
  • Spray on tattoo artwork exposed to the elements
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, SD Alcohol 40-B, Styrene/Acrylates Copolymer, Glycerin, Sodium Hydroxide, Methylcellulose, Disodium EDTA

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excesive heat and direct sun.
  • if it becomes hard to pump, hold tube under water for 15 seconds

Questions or comments?

OTC - QUESTIONS SECTION

P.O. Box 265849 Daytona Beach, FL 32126

Tattoo Color Guard SPF 15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-030758443-0307-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
ENSULIZOLE9YQ9DI1W42ACTIB
ALCOHOL3K9958V90MIACT

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
dec39beb-6555-40a1-e053-2a95a90aafafb21e876a-0bdb-0dd5-e053-2a95a90aa4b92022-05-11WarningsExact identifier
spl set id: b21e876a-0bdb-0dd5-e053-2a95a90aa4b9

Reported adverse events (FAERS/openFDA)#

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