JULEP DAYLIGHT DEFENSE FOR HANDS AND FACE SPF 30- octinoxate, oxybenzone, zinc oxide and ensulizole cream
Julep Nail Parlor Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients: Octinoxate 7.5%, Oxybenzone 4.0%, Zinc Oxide 3.0%, Ensulizole 2.0%

Purpose:Sunscreen

Uses: Helps prevent sunburn.

Warnings:

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 help prevent sunburn, not skin cancer or early skin aging.

For External Use only.

Do Not use on damaged or broken skin.

UV exposure form the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using sunscreen.

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

Stop use and ask a doctor if rash occurs

Enter section text here

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

Directions

Apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at lease every 2 hours
children under 6 months: Ask a doctor

Inactive Ingredients

Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Ceteth-10 Phosphate, Citrus Aurantium Dulcis (Orange) Oil, Cyclomethicone, Dicetyl Phosphate, Dimethicone, Glycerin, Hexylene Glycol, Isononyl Isononanoate, Magnesium Aluminum Silicate, Octyldodecyl Neopentanoate, Phenoxyethanol, Potassium Hydroxide, PVP/Eicosene Copolymer, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Triethxycarylylsilane, Water, Xanthan Gum

Other Information protect this product from excessive heat and direct sun

Questions or comments?

Call 877-585-3707

Distributed by Julep Nail Parlor Co.

Seattle, WA 98119 / julep.com 877 585-3707 Made in USA

JulepDaylight defense

Julep

SPF 30

daylight defense for Hands and Face

89ml 3 FL OZ

JULEP DAYLIGHT DEFENSE FOR HANDS AND FACE SPF 30
octinoxate, oxybenzone, zinc oxide, esulizole cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:76280-197
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	7.5 g in 100 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	4 g in 100 mL
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	3 g in 100 mL
ENSULIZOLE (ENSULIZOLE)	ENSULIZOLE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
GLYCERIN
CYCLOMETHICONE
CETOSTEARYL ALCOHOL
1,3-BUTYLENE GLYCOL
DIHEXADECYL PHOSPHATE
CETETH-10
MAGNESIUM ALUMINUM SILICATE
ORANGE OIL
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE, D-
DIMETHICONE
XANTHAN GUM
POTASSIUM HYDROXIDE
CAPRYLYL GLYCOL
PHENOXYETHANOL
HEXYLENE GLYCOL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76280-197-01	89 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2012	12/01/2013

Labeler - Julep Nail Parlor Company (023413483)

Revised: 12/2013

Document Id: 6865b1b5-2230-4a7d-96a6-0548365ab13b

Set id: 9ce9bf48-ecb9-411d-9081-ceea0a5a5c5d

Version: 7

Effective Time: 20131216

Julep Nail Parlor Company