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

Jason Pure Natural Sun Kids Natural Sunscren Broad Spectrum SPF45 by

Drug Labeling and Warnings

Jason Pure Natural Sun Kids Natural Sunscren 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 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 your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF15 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), Calendula Officinalis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), 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).

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0322
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)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0322-4	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/11/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture(61995-0322)