FDA.reportPublic FDA data

JACK BLACK INK BOOST TATTOO CARE

Manufacturer
Jack Black L.L.C | Swiss American CDMO
Effective date
2024-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:04:33

Label at a glance#

ProductJACK BLACK INK BOOST TATTOO CARE
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure12 sections

Indications and uses

Helps prevent sunscreen.

Dosage and administration

Apply liberally15 minutes before sun exporsure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every two hours Children under 6 months: 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 sunscreen with a broad-spectrum SPF value of 15 or higher and othe sun protection...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 3.0%

Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunscreen.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs

OTC - WHEN USING SECTION

When using this product keep out of eyes.

Rinse with water to remove.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally15 minutes before sun exporsure
  • Reapply: After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every two hours
  • Children under 6 months: 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 sunscreen with a broad-spectrum SPF value of 15 or higher and othe sun protection measures including:
  • Limit time in the sun, expecially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cyclopentasiloxane, Ethylhexyl Isononanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Calendula Officinalis (Calendula) Flower Extract*, Peucedanum Ostruthium Leaf Extract*, Buddleja Davidii Leaf Extract*, Artemisia Ubelliformis Extract*, Leontopodium Alpinum (Edelweiss) Extract*, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Sodium Chloride, Triethoxycaprylylsilane, Dimethicone/PEG-10/15 Crosspolymer, Iodopropynyl Butylcarbamate, Ascorbyl Palmitate, Retinyl Palmitate

*Certified Organic

Questions?

OTC - QUESTIONS SECTION

1-877-766-3388

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jack Black Sun GuardJack Black Sun GuardJack Black

Sun Guard

Broad-Spectrum SPF 45 Sunscreen

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66738-381-402024-04-23C16284748780-1f386c649-ee48-0266-e053-dadaa90a7c1aaecfa93f-5508-01c8-e053-2a95a90a239a
66738-381-402023-01-30C16284748780-1f386c649-ee48-0266-e053-dadaa90a7c1aaecfa93f-5508-01c8-e053-2a95a90a239a

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66738-38166738-381-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ASCORBYL PALMITATEQN83US2B0NIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOPQQC1AK06RKIACT
PEUCEDANUM OSTRUTHIUM LEAF86P27YRR6YIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
BUDDLEJA DAVIDII LEAFX380815D32IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ARTEMISIA UMBELLIFORMIS FLOWER91OLL9AJ7DIACT

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
16c8f2b2-b1ba-a255-e063-6394a90a8079aecfa93f-5508-01c8-e053-2a95a90a239a2024-04-23WarningsExact identifier
spl id: 16c8f2b2-b1ba-a255-e063-6394a90a8079
spl set id: aecfa93f-5508-01c8-e053-2a95a90a239a

Reported adverse events (FAERS/openFDA)#

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