Jurlique Purely Sun-Defying Moisturizer with SPF 15 Sunscreen

Dosage form: cream, augmented
Ingredients: ZINC OXIDE 4.8g in 100g, TITANIUM DIOXIDE 2.1g in 100g
Labeler: Jurlique International Pty. Ltd.
NDC Code: 68105-004

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.

Jurlique
Purely Sun-Defying

Drug Facts

Active ingredientsPurpose
Zinc Oxide, 4.8%
Titanium Dioxide, 2.1%
Sunscreen

Use
  • 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 prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

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
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor

Other information
  • protect this product from excessive heat and direct sun
  • you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-022

Inactive ingredients

Water, Simmondsia chinensis (Jojoba) Seed Oil, Glyceryl Stearate Citrate, Glycerin, Caprylic/Capric Triglyceride, Macadamia integrifolia Seed Oil, Mauritia flexuosa Fruit Oil, Sorbitan Palmitate, Glyceryl Isostearate, Porphyra umbilicalis Extract, Ectoin, Sambucus nigra (Black Elder) Flower Extract, Viola tricolor (Pansy) Extract, Viola odorata (Sweet Violet) Extract, Glycyrrhiza glabra (Licorice) Root Extract, Rosa gallica Flower Extract, Chamomilla recutita (Matricaria) Flower Extract, Althaea officinalis (Marshmallow) Root Extract, Polyhydroxystearic Acid, Lecithin, Sodium Lactate, Aluminum Hydroxide, Hydrated Silica, Alginic Acid, Beta-Glucan, Sodium Hyaluronate, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Sodium Phytate, Bisabolol, SD Alcohol 40-A, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, Totarol, Citrus medica limonum (Lemon) Peel Oil, Lavandula angustifolia (Lavender) Oil, Pelargonium graveolens Flower Oil, Fusanus spicatus Wood Oil, Citrus aurantium dulcis (Orange) Flower Oil, Anthemis nobilis Flower Extract, Pogostemon cablin Oil, Jasminum officinale (Jasmine) Flower Extract, Canarium luzonicum Gum Nonvolatiles.

PRINCIPAL DISPLAY PANEL - 40g Tube Carton

Jurlique

Purely Sun-Defying

Moisturizer with
SPF 15 Sunscreen

A high performance
protective cream

e 40g Net wt. 1.4 oz.

JURLIQUE PURELY SUN-DEFYING   MOISTURIZER WITH SPF 15 SUNSCREEN
zinc oxide and titanium dioxide cream, augmented
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68105-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE4.8 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SIMMONDSIA CHINENSIS SEED 
GLYCERYL STEARATE CITRATE 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
MACADAMIA OIL 
MAURITIA FLEXUOSA FRUIT OIL 
SORBITAN MONOPALMITATE 
GLYCERYL ISOSTEARATE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
EGG PHOSPHOLIPIDS 
ALCOHOL 
SODIUM LACTATE 
ALUMINUM HYDROXIDE 
HYDRATED SILICA 
ALGINIC ACID 
SAMBUCUS NIGRA FLOWER 
VIOLA TRICOLOR 
VIOLA ODORATA 
GLYCYRRHIZA GLABRA 
ROSA GALLICA FLOWER 
CHAMOMILE 
ALTHAEA OFFICINALIS ROOT 
HYALURONATE SODIUM 
ECTOINE 
XANTHAN GUM 
LEVOMENOL 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
CHLORPHENESIN 
LEMON OIL 
LAVENDER OIL 
PELARGONIUM GRAVEOLENS FLOWER OIL 
SANTALUM SPICATUM OIL 
CITRUS SINENSIS FLOWER OIL 
CHAMAEMELUM NOBILE FLOWER 
PATCHOULI OIL 
JASMINUM OFFICINALE FLOWER 
ELEMI 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68105-004-0140 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/01/2011
Labeler - Jurlique International Pty. Ltd. (752025791)
Establishment
NameAddressID/FEIOperations
Cosmetic Laboratories of America617165329MANUFACTURE

Revised: 09/2011
 
Jurlique International Pty. Ltd.

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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