JACK BLACK SUN GUARD SUNSCREEN SPF45- sunscreen lotion

Jack Black Sun Guard Sunscreen SPF45 by

Drug Labeling and Warnings

Jack Black Sun Guard Sunscreen SPF45 by is a Otc medication manufactured, distributed, or labeled by Jack Black, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octisalate   3.0%   Sunscreen

Octinoxate   7.5%   Sunscreen

Zinc Oxide   8.0%   Sunscreen

Uses

Helps prevent sunburn

Warnings

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask doctor if rash occurs
• When using this product keep out of eyes
• Rinse with water to remove
• Keep out of reach of children
• If swallowed, get medical help or contact Poison Control Cneter right away

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply: after 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every two hours
• Children under 6 months: ask a doctor
• 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 SFP value of 15 or higher
• Limit time in the sun, eespecially from 10 a.m. - 2 p.m.

Inactive Ingredients

Artemisia Umbelliformis Extract, Ascorbyl Palmitate, Buddleja Davidii Leaf Extract, Butylene Glycol, Calendula Officinalis Flower Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isononanoate, Glycerin, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxethyl Dimethicone, Leontopodium Aloinum (Edelweiss) Extract, Penoxyethanol, Peucedanum Ostruthium Leaf Extract, Retinyl Palmitate, Sodium Chloride, Triethoxycaprylylsilane, Water

Other Information

• Protect product from exessive heat and direct sunlight.
• You  may report a serious adverse reaction from using this product to Jack Black at 1-877-766-3388

Questions

1-877-766-3388

www.getjackblack.com

Label

INGREDIENTS AND APPEARANCE

JACK BLACK SUN GUARD SUNSCREEN SPF45 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)
PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)
ARTEMISIA UMBELLIFORMIS FLOWER (UNII: 91OLL9AJ7D)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white (off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-304-14	113 g in 1 TUBE; Type 0: Not a Combination Product	02/09/2010
2	NDC: 66738-304-27	44 g in 1 TUBE; Type 0: Not a Combination Product	02/04/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/09/2010

Labeler - Jack Black, LLC (847024036)