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Julep daylight defense for hands and face SPF 30

Dosage form: cream
Ingredients: OCTINOXATE 7.5g in 100mL, OXYBENZONE 4g in 100mL, ZINC OXIDE 3g in 100mL, ENSULIZOLE 2g in 100mL
Labeler: Julep Nail Parlor Company
NDC Code: 76280-197

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.

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


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 TypeHUMAN OTC DRUGItem Code (Source)NDC:76280-197
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4 g  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE3 g  in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:76280-197-0189 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2012
Labeler - Julep Nail Parlor Company (023413483)

Revised: 06/2013
 
Julep Nail Parlor Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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