J0832706 JASON SUN FACIAL SUNSCREEN SPF20- homosalate, octyl salicylate, octocrylene, avobenzone lotion

J0832706 Jason Sun Facial Sunscreen SPF20 by

Drug Labeling and Warnings

J0832706 Jason Sun Facial Sunscreen SPF20 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

Active Ingredient

Avobenzone - 2.0%

Homosalate - 7.5%

Octocrylene -5.0%

Octyl Salicylate - 3.0%

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.Use a water resistant sunscreenif swimming or sweating. Reapply at least every 2 hours. Children under 6 months, ask a doctor

PURPOSE

Sunscreen

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 Poison Center right away.

INACTIVE INGREDIENT

Water, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Dimethicone, VP/Hexadecene Copolymer, Aloe Barbadensis Leaf Juice(1), CalenduCamellia Sinensis Leaf Extract (1), ChamoVitis Venifera (Grape) Seed Extract (1), Tocopheryl Acetate, Cetearyl Olivate, Citric Acid, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Alcohol (1), Potassium Sorbate, Sodium Benzoate, BenDehydroacetic Acid, Phenoxyethanol.

(1) Certified Organic Ingredient

INDICATIONS & USAGE

Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

J0832706 JASON SUN FACIAL SUNSCREEN SPF20 
homosalate, octyl salicylate, octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0027-4	128 g in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/20/2017

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		117115556	manufacture(61995-0027)