JASON PURE NATURAL SUN FAMILY NATURAL SUNSCREEN BROAD SPECTRUM SPF45- homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide lotion

Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum SPF45 by

Drug Labeling and Warnings

Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum SPF45 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate  10.0%

Octocrylene  10.0%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicylate  5.0%

Titanium Dioxide  2.0%

PURPOSE

Sunscreens

INDICATIONS & USAGE

• Helps prevent sunburns
• If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by the sun.
  

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 skin rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

• Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating after towel drying, or at least every 2 hours. Children under 6 months, ask a doctor . Skin Protection Measures: Spending time in the sun increases immediately  your risk of skin cancer and early skin aging.To decrease risk, regularly use a sunscreen  with Broad Spectrum SPF 15 or higher and other protective measures including:

• Limit time in the sun, especially from 10am to 2pm
  
• Wear long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT

 Aqua (Water), Cetearyl Alcohol, Glycerin, Cetyl Alcohol,Dimethicone, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride,Glyceryl Stearate SE, Hydrogenated Palm Kernel Oil, Aloe Barbadensis Leaf Juice (1),Camellia Sinensis Leaf Extract (1),Cucumis Sativus (Cucumber) Fruit Extract, Cetearyl Olivate, Polysorbate 60, Silica, Sodium Stearoyl Glutamate, Sorbitan Olivate,Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Fragrance (Parfum).

(1) Certified Organic Ingredients

QUESTIONS

Questions? Call 1-877-JASON-01or visit www.jason-natural.com

PRINCIPAL DISPLAY PANEL

            

INGREDIENTS AND APPEARANCE

JASON PURE NATURAL SUN FAMILY NATURAL SUNSCREEN BROAD SPECTRUM SPF45 
homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
CUCUMBER (UNII: YY7C30VXJT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0300-4	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/11/2011

Labeler - The Hain Celestial Group, Inc. (858894996)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture