Drug Facts

SUNBRELLAS SPORT SUNBLOCK SPF 45 - homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide cream
The Hain Celestial Group

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.

----------

Drug Facts

ACTIVE INGREDIENTS

Homosalate 10.0%

Octocrylene 10.0%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicilate 5.0%

Titanium Dioxide 2.0%

USES

Helps prevent sunburns
Higher SPF gives more sunburn protection
Moderate sun protection product
Apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure
Reapply as needed after towel drying, swimming or sweating
Children after 6 months, ask doctor

WARNINGS

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away.

OTHER INFORMATION

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

QUESTIONS?

1-877-JASON-01

www.jason-natural.com

JASON NATURAL PRODUCTS

The Hain Celestial Group, Inc.

Melville, NY 11747

Made in U.S.A.

image of tube label

SUNBRELLAS SPORT SUNBLOCK SPF 45
homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61995-0201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10.0 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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61995-0201-4	113 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/03/2009

Labeler - The Hain Celestial Group (858894996)

Name	Address	ID/FEI	Business Operations
Establishment
The Hain Celestial Group		858894996	manufacture