JURLIQUE PURELY SUN-DEFYING- zinc oxide and titanium dioxide cream, augmented

Jurlique Purely Sun-Defying by

Drug Labeling and Warnings

Jurlique Purely Sun-Defying by is a Otc medication manufactured, distributed, or labeled by Jurlique International Pty. Ltd., Cosmetic Laboratories of America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients		Purpose
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.

INGREDIENTS AND APPEARANCE

JURLIQUE PURELY SUN-DEFYING   MOISTURIZER WITH SPF 15 SUNSCREEN
zinc oxide and titanium dioxide cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68105-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.8 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MACADAMIA OIL (UNII: 515610SU8C)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ALGINIC ACID (UNII: 8C3Z4148WZ)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
VIOLA TRICOLOR (UNII: 9Q24RAI43V)
VIOLA ODORATA (UNII: AET12U8B74)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ROSA GALLICA FLOWER (UNII: X8W61WUV70)
CHAMOMILE (UNII: FGL3685T2X)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ECTOINE (UNII: 7GXZ3858RY)
XANTHAN GUM (UNII: TTV12P4NEE)
LEVOMENOL (UNII: 24WE03BX2T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
LEMON OIL (UNII: I9GRO824LL)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
PATCHOULI OIL (UNII: F3IN55X5PO)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
ELEMI (UNII: C13XI009KO)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68105-004-01	40 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	11/01/2011

Labeler - Jurlique International Pty. Ltd. (752025791)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Laboratories of America		617165329	MANUFACTURE