Julep Everyday SPF 30 Hand Cream

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

Purpose:Sunscreen

Uses: Helps prevent sunburn. Provides moderate protection against sunburn. Higher SPF gives more sunburn protection.

Warnings:UV exposure from th 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. For external use only. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.

Keep out of reach of children

Directions: Apply to hands 30 minutes before sun exposure. Reapply as needed after towel drying, swimming or sweating. Children under 6 months of age: consult 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 (Vitamin E), Triethxycaprylylsilane, Water, Xanthan Gum.

Julep

Everyday

SPF 30 Hand Cream

89mL 3 fl oz

JULEP EVERYDAY HAND SPF 30
octinoxate, oxybenzone, zinc oxide, esulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76280-188
Route of Administration	TOPICAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
WATER
GLYCERIN
CYCLOMETHICONE
CETOSTEARYL ALCOHOL
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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:76280-188-01	89 mL in 1 TUBE	None
2	NDC:76280-188-02	2 mL in 1 PACKET	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2011

Labeler - Julep Nail Parlor Company (023413483)

Revised: 07/2011 Julep Nail Parlor Company