J0830014 JASON SUN FAMILY SUNSCREEN SPF45- homosalate, octyl salicylate, octocrylene, avobenzone lotion 
The Hain Celestial Group, Inc.

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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Jason Family Sunscreen SPF 45

Active Ingredient

Avobenzone - 3%

Homosalate - 10.0%

Octocrylene -10.0%

Octyl Salicylate - 5.0%

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.

Sunscreen

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. If swallowed get medical help or contact Poison Center right away.

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

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.

J08300 Label

J0830014 JASON SUN FAMILY SUNSCREEN SPF45 
homosalate, octyl salicylate, octocrylene, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0014-4113 g in 1 TUBE; Type 0: Not a Combination Product02/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/07/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (081512382)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-0014)

Revised: 4/2021
Document Id: bfc79738-95ca-b1c2-e053-2a95a90ad7d9
Set id: 480a30ad-2c57-050b-e054-00144ff8d46c
Version: 5
Effective Time: 20210412
 
The Hain Celestial Group, Inc.