Sunforgettable® Brush-On Sunscreen SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

SUNFORGETTABLE BRUSH-ON SUNSCREEN SPF 50- titanium dioxide and zinc oxide powder 
Colorescience

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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Sunforgettable® Brush-On Sunscreen SPF 50

Drug Facts

Active ingredients	Purpose
Titanium Dioxide 23.9%	Sunscreen
Zinc Oxide 24.1%	Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every two hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor.
• Sun Protection Measures
  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.– 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredients

Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Lithothamnion Calcareum Extract, Mannitol, Methicone, Dimethicone, Calcium Silicate, Triethoxycaprylylsilane, Sodium Sulfate, Laureth-4, Diatomaceous Earth, Zinc Sulfate, Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 866.426.5673

Distributed in USA by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

colorescience®

SUNFORGETTABLE®
BRUSH-ON
SUNSCREEN

Fights skin aging

Mess-free powder

Immediate on-the-go
protection

50
Broad Spectrum
SPF 50
Sunscreen

Net Wt. 6 g / 0.21 oz.

SUNFORGETTABLE BRUSH-ON SUNSCREEN SPF 50 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	239 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	241 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Dimethicone/vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Phymatolithon Calcareum (UNII: 6J1M3WA0ZK)
Mannitol (UNII: 3OWL53L36A)
Methicone (20 CST) (UNII: 6777U11MKT)
Dimethicone (UNII: 92RU3N3Y1O)
Calcium Silicate (UNII: S4255P4G5M)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Sodium Sulfate (UNII: 0YPR65R21J)
Laureth-4 (UNII: 6HQ855798J)
Diatomaceous Earth (UNII: 2RF6EJ0M85)
Zinc Sulfate, Unspecified Form (UNII: 89DS0H96TB)
Chromic Oxide (UNII: X5Z09SU859)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-022-23	1 in 1 CARTON	02/01/2017	06/03/2019
1		6 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2017	06/03/2019

Labeler - Colorescience (128731929)

Revised: 6/2019

Document Id: 8be5f63d-701a-4d72-9420-51c034f11fc2

34390-5

Set id: 7743d2d3-4ee9-40bc-bc6a-6c2d33c17a8e

Version: 2

Effective Time: 20190628