OTC Medication Information: J0830014 Jason Sun Family Sunscreen SPF45

J0830014 JASON SUN FAMILY SUNSCREEN SPF45- homosalate, octisalate, octocrylene and 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.

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
SODIUM STEAROYL GLUTAMATE
.ALPHA.-TOCOPHEROL ACETATE
GLYCERYL STEARATE SE
POTASSIUM SORBATE
CETYL ALCOHOL
DIMETHICONE
XANTHAN GUM
CETOSTEARYL ALCOHOL
POLYSORBATE 60
MEDIUM-CHAIN TRIGLYCERIDES
CETEARYL OLIVATE
SODIUM CHLORIDE
SORBITAN OLIVATE
SODIUM BENZOATE
BENZYL ALCOHOL
ALLYL HEXANOATE
CITRIC ACID MONOHYDRATE
GREEN TEA LEAF
CUCUMBER
ALOE VERA LEAF
GLYCERIN
WATER
CANANGA OIL
BENZYL BENZOATE
ORANGE OIL
ETHYL ACETATE
ISOAMYL ACETATE
VANILLIN
LIMONENE, (+)-
LINALOOL, (+/-)-
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-0014-4 113 g in 1 TUBE None
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. (081512382)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 081512382 manufacture (61995-0014)

Revised: 04/2021 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.