JACK BLACK DUAL DEFENSE FACE MOISTURIZER - SPF 30- titanium dioxide, zinc oxide lotion

Jack Black Dual Defense Face Moisturizer - SPF 30 by

Drug Labeling and Warnings

Jack Black Dual Defense Face Moisturizer - SPF 30 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 ingredients

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, Azelaic Acid, Allantoin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract*, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Vaccinium Macrocarpon (Cranberry) Fruit Extract*, Silica, Alumina, Isohexadecane, Hydrogenated Lecithin, Polyhydroxystearic Acid, Xylitol, Stearic Acid, Niacinamide, Polysorbate 60, Oryza Sativa (Rice) Extract, Triethoxycaprylylsilane, Xanthan Gum, Aminomethyl Propanol, Sorbitan Isostearate, Hydrogenated Phosphatidylcholine, Methicone, Citric Acid, Phenoxyethanol. 21002 *Certified Organic

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JACK BLACK DUAL DEFENSE FACE MOISTURIZER - SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-501
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
RICE GERM (UNII: 7N2B70SFEZ)
HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE (UNII: QHQ97HF0PY)
CRANBERRY (UNII: 0MVO31Q3QS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ROSEMARY (UNII: IJ67X351P9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XYLITOL (UNII: VCQ006KQ1E)
STEARIC ACID (UNII: 4ELV7Z65AP)
NIACINAMIDE (UNII: 25X51I8RD4)
XANTHAN GUM (UNII: TTV12P4NEE)
AZELAIC ACID (UNII: F2VW3D43YT)
ALLANTOIN (UNII: 344S277G0Z)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
METHICONE (20 CST) (UNII: 6777U11MKT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-501-01	1 in 1 CARTON	01/01/2023
1	NDC: 66738-501-21	59 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/01/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source L.L.C		080354456	manufacture(66738-501)