JACK BLACK- titanium dioxide, zinc oxide lotion

Jack Black by

Drug Labeling and Warnings

Jack Black by is a Otc medication manufactured, distributed, or labeled by Jack Black L.L.C, Pure Source L.L.C. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Titanium Dioxide 3.9%

Zinc Oxide 3.2%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

Directions

Apply liberally 15 minutes before sun exposure Children under 6 months of age: Ask a doctor Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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

■ Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Butyloctyl Salicylate, Propanediol, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Silica, Azelaic Acid, Allantoin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract*, Vaccinium Macrocarpon (Cranberry) Fruit Extract*, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Niacinamide, Oryza Sativa (Rice) Extract, Alumina, Isohexadecane, Hydrogenated Lecithin, Polyhydroxystearic Acid, Xylitol, Stearic Acid, Polysorbate 60, Triethoxycaprylylsilane, Xanthan Gum, Aminomethyl Propanol, Sorbitan Isostearate, Hydrogenated Phosphatidylcholine, Citric Acid, Phenoxyethanol. 24012 *Certified Organic

Questions?

www.getJackBlack.com 1-877-766-3388; 1-469-341-2700

Principal Display Panel

Jack Black

Authentic and Original

Dual Defense

Face Moisturizer

100% Mineral Sunscreen

Broad Spectrum SPF 30

with Hyaluronic Acid

& Niacinamide

SPF 30

59 mL / 2 FL OZ

Jack Black

Authentic and Original

Dual Defense

Face Moisturizer

100% Mineral Sunscreen

Broad Spectrum SPF 30

with Hyaluronic Acid

& Niacinamide

SPF 30

59 mL / 2 FL OZ

Jack Black

Authentic and Original

Dual Defense

Face Moisturizer

100% Mineral Sunscreen

Broad Spectrum SPF 30

with Hyaluronic Acid

& Niacinamide

SPF 30

15 mL / 0.5 FL OZ

INGREDIENTS AND APPEARANCE

JACK BLACK 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.9 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DECAMETHYLTETRASILOXANE (UNII: C23WAL597T)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ROSEMARY (UNII: IJ67X351P9)
WATER (UNII: 059QF0KO0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
NIACINAMIDE (UNII: 25X51I8RD4)
AZELAIC ACID (UNII: F2VW3D43YT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE (UNII: QHQ97HF0PY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PEG-60 SORBITAN STEARATE (UNII: 073G38N8GC)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
RICE GERM (UNII: 7N2B70SFEZ)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISOHEXADECANE (UNII: 918X1OUF1E)
CRANBERRY (UNII: 0MVO31Q3QS)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-502-01	1 in 1 CARTON	07/31/2024
1	NDC: 66738-502-22	59 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 66738-502-21	14 mL in 1 PACKET; Type 0: Not a Combination Product	07/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/31/2024

Labeler - Jack Black L.L.C (847024036)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source L.L.C		080354456	manufacture(66738-502)