JURLIQUE SPF40 HIGH PROTECTION SUNSCREEN- avobenzone, octinoxate, and octocrylene cream

Jurlique SPF40 High Protection Sunscreen by

Drug Labeling and Warnings

Jurlique SPF40 High Protection Sunscreen by is a Otc medication manufactured, distributed, or labeled by Jurlique International, Cosmetic Laboratories of America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Avobenzone, 3.0%
Octinoxate, 7.5 %
Octocrylene, 2.75%
Purpose

Sunscreen
Use
- help prevent sunburn
Warnings

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
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- – Limit time in the sun, especially from 10 a.m.-2 p.m.
- – Wear long-sleeved shirts, pants, hats and sunglasses
Other information
- protect this product from excessive heat and direct sun
- Store below 30°C/86°F
- product may cause discolouration in contact with some fabric
- patch testing on skin recommended before use, discontinue use if signs of irritation occur
- you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-022
Inactive ingredients

Water, Phenoxyethyl Caprylate, Acrylates/Vinyl Neodecanoate Crosspolymer, Glycerin, Ethylhexyl Methoxycrylene, Diethylhexyl Syringylidenemalonate, Glyceryl Stearate, VP/Eicosene Copolymer, Cetearyl Alcohol, Myristyl Myristate, Sodium Stearoyl Glutamate, Plukenetia volubilis Seed Oil, Butyrospermum parkii (Shea) Butter, Palmaria palmata Extract, Ascophyllum nodosum Extract, Fucus vesiculosus Extract, Porphyra umbilicalis Extract, Corandrum sativum (Coriander) Extract, Chamomilla recutita (Matricaria) Flower Extract, Rosa gallica Flower Extract, Glycyrrhiza glabra (Licorice) Extract, Viola odorata Extract, Viola tricolor Extract, Sambucus nigra Flower Extract, Camellia sinensis Leaf Extract, Cucumis sativus (Cucumber) Fruit Extract, Tasmannia lanceolata Fruit Extract, Syzygium leuhmanii Extract, Kunzea pomifera Fruit Extract, Fragrance/Parfum1, Silica, Acrylates/Beheneth-25 methacrylate Copolymer, Xanthan Gum, Sodium Stearoyl Lactylate, Tocopherol, SD Alcohol 40-A (Alcohol Denat.), Sodium Phytate, Caprylic/Capric Triglyceride, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, Sodium Dehydroacetate, Benzyl Alcohol, Sodium PCA, Sodium Hydroxide, Limonene1, Linalool1, Citronellol1, Geraniol1, Farnesol1, Citral1.

1 From Essential Oil

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

Jurlique

Sun Specialist
with Superberry Complex

SPF40
High Protection Cream
PA+++

Protective broad spectrum
sunscreen for face and body

100mL 3.3 fl. oz.

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

INGREDIENTS AND APPEARANCE

JURLIQUE SPF40 HIGH PROTECTION SUNSCREEN
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68105-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Phenoxyethyl Caprylate (UNII: GMI5AN7T8U)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
Glycerin (UNII: PDC6A3C0OX)
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Copovidone K25-31 (UNII: D9C330MD8B)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Myristyl Myristate (UNII: 4042ZC00DY)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Ascophyllum nodosum (UNII: 168S4EO8YJ)
Fucus vesiculosus (UNII: 535G2ABX9M)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
Coriander (UNII: 1OV56052IK)
Chamomile (UNII: FGL3685T2X)
Rosa Gallica Flower (UNII: X8W61WUV70)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Viola Odorata (UNII: AET12U8B74)
Viola tricolor (UNII: 9Q24RAI43V)
European Elderberry (UNII: BQY1UBX046)
Bancha Tea Leaf/Twig (UNII: EWI42IEH1C)
Cucumber (UNII: YY7C30VXJT)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)
Tocopherol (UNII: R0ZB2556P8)
Alcohol (UNII: 3K9958V90M)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Benzyl Alcohol (UNII: LKG8494WBH)
Phytate Sodium (UNII: 88496G1ERL)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 68105-006-01	1 in 1 CARTON	01/01/2015
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/01/2015

Labeler - Jurlique International (752025791)

Registrant - Cosmetic Laboratories of America (013696501)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Laboratories of America		013696501	MANUFACTURE(68105-006)