OTC Medication Information: Sunbrellas Kids Sunblock SPF 45

SUNBRELLAS KIDS SUNBLOCK SPF 45 — homosalate, octocrylene, octinoxate, octisalate and titanium dioxide cream
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 INGREDIENTS

Homosalate 10.0%

Octocrylene 10.0%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicilate 5.0%

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 under 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
(click image for full-size original)

SUNBRELLAS KIDS SUNBLOCK SPF 45
homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicilate, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0204
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate (Homosalate) Homosalate 10 g in 100 g
Octocrylene (Octocrylene) Octocrylene 10 g in 100 g
Octinoxate (Octinoxate) Octinoxate 7.5 g in 100 g
Octisalate (Octisalate) Octisalate 5.0 g in 100 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 2.0 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-0204-4 113 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 11/03/2009
Labeler — The Hain Celestial Group, Inc. (858894996)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 858894996 manufacture

Revised: 07/2010 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.

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