Sunforgettable® Eyescreen SPF 30 Sunscreen

Drug Labeling and Warnings

Drug Details [pdf]

SUNFORGETTABLE EYESCREEN SPF 30 SUNSCREEN- 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® Eyescreen SPF 30 Sunscreen

Drug Facts

Active ingredients

Titanium Dioxide 11.6%
Zinc Oxide 11.8%

Purpose

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.

Other information

Protect this product from excessive heat and direct sun.

Directions

• Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
• Reapply:
  • After 40 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
• 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

Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Laureth-4, Lithothamnium Calcareum Extract, Calcium Silicate, Dimethicone, Methicone, Mannitol, Triethoxycaprylylsilane, Diatomaceous Earth, Zinc Sulfate, Sodium Sulfate, Iron Oxides (CI 77491)

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 1.5 g Tube Carton

colorescience® eyescreen

SPF 30

sunforgettable®

BROAD SPECTRUM SPF 30
SUNSCREEN
WATER RESISTANT
(40 MINUTES)

Net Wt. 0.05 oz / 1.5 g

SUNFORGETTABLE EYESCREEN SPF 30 SUNSCREEN 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	116 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	118 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-011-12	1 in 1 CARTON	10/05/2015	04/13/2018
1		1.5 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	10/05/2015	04/13/2018

Labeler - Colorescience (128731929)

Revised: 6/2019

Document Id: 733843ef-55b7-4c63-8749-03ebc4c383da

34390-5

Set id: 73c13ce1-adf1-42a3-864f-37baacdda342

Version: 2

Effective Time: 20190628