JURLIQUE SUN SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone, and titanium dioxide cream, augmented

Jurlique Sun Sunscreen SPF 30 by

Drug Labeling and Warnings

Jurlique Sun Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Jurlique International Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 2.0%
Oxybenzone 5.0%
Titanium dioxide 2.1%

Purpose

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 help 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 sunlight
• store below 25°C/77°F
• you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

Water, Glycerin, Ethylhexyl Stearate, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Glyceryl Stearate, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexyl Palmitate, Dimethicone, Trimethylsiloxysilicate, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Sodium Hydroxymethylglycinate, Lactic Acid, Alumina, Stearic Acid, Xanthan Gum, Cetyl Alcohol, Lavandula Angustifolia (Lavender) Oil, Pinus Sylvestris (Pine) Leaf Oil, Cupressus Sempervirens (Cypress) Oil, Citrus Aurantium Amara (Bitter Orange) Oil, Linalool, Limonene.

PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton

Jurlique

Sun Lotion

SPF 30

A protective sunscreen lotion

100mL 3.3 Fl. Oz.

INGREDIENTS AND APPEARANCE

JURLIQUE SUN SUNSCREEN SPF 30 
octinoxate, octisalate, oxybenzone, and titanium dioxide cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68105-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	20 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	21 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
Ethylhexyl Palmitate (UNII: 2865993309)
Dimethicone (UNII: 92RU3N3Y1O)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Sodium Hydroxymethylglycinate (UNII: DIG6BWZ9XT)
Lactic Acid (UNII: 33X04XA5AT)
Aluminum Oxide (UNII: LMI26O6933)
Stearic Acid (UNII: 4ELV7Z65AP)
Xanthan Gum (UNII: TTV12P4NEE)
Cetyl Alcohol (UNII: 936JST6JCN)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Product Characteristics
Color	WHITE (Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68105-005-03	1 in 1 CARTON
1	NDC: 68105-005-01	100 mL in 1 BOTTLE, PUMP
2	NDC: 68105-005-04	1 in 1 CARTON
2	NDC: 68105-005-02	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2013

Labeler - Jurlique International Pty. Ltd. (752025791)

Establishment
Name	Address	ID/FEI	Business Operations
Jurlique International Pty. Ltd.		752025791	MANUFACTURE(68105-005)