J0830014 JASON SUN FAMILY SUNSCREEN SPF45- homosalate, octyl salicylate, octocrylene, avobenzone lotion

J0830014 Jason Sun Family Sunscreen SPF45 by

Drug Labeling and Warnings

J0830014 Jason Sun Family Sunscreen 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

Active Ingredient

Avobenzone - 3%

Homosalate - 10.0%

Octocrylene -10.0%

Octyl Salicylate - 5.0%

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.

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, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Flower Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1),Cucumis Sativus (Cucumber) Fruit Extract, Tocopheryl Acetate, Allyl Caproate, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Ethyl Acetate, Gamma-Nonelactone, Isoamyl Acetate, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Vanillin, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Benzyl Benzoate, Limonene, Linalool.

(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

J0830014 JASON SUN FAMILY SUNSCREEN SPF45 
homosalate, octyl salicylate, octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0014
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALLYL HEXANOATE (UNII: 3VH84A363D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CANANGA OIL (UNII: 8YOY78GNNX)
BENZYL BENZOATE (UNII: N863NB338G)
ORANGE OIL (UNII: AKN3KSD11B)
ETHYL ACETATE (UNII: 76845O8NMZ)
ISOAMYL ACETATE (UNII: Z135787824)
VANILLIN (UNII: CHI530446X)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0014-4	113 g in 1 TUBE; Type 0: Not a Combination Product	02/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/07/2017

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(61995-0014)