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

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.

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Jurlique SPF40 High Protection Sunscreen

Drug Facts

Active ingredients

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

Purpose

Sunscreen

Use

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

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

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
JURLIQUE SPF40 HIGH PROTECTION SUNSCREEN 
avobenzone, octinoxate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68105-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68105-006-011 in 1 CARTON01/01/2015
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2015
Labeler - Jurlique International (752025791)
Registrant - Cosmetic Laboratories of America (013696501)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Laboratories of America013696501MANUFACTURE(68105-006)

Revised: 7/2016
Document Id: d1410464-efb4-487f-a76a-a3c6abc956a1
Set id: 80683894-06ed-42f4-aa32-0fd4eb7e9166
Version: 1
Effective Time: 20160725
 
Jurlique International