Sunforgettable® Loose Mineral Sunscreen SPF 30

Drug Labeling and Warnings

Drug Details [pdf]

SUNFORGETTABLE LOOSE MINERAL SUNSCREEN SPF 30- 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® Loose Mineral Sunscreen SPF 30

Drug Facts

Active ingredients	Purpose
Titanium Dioxide 21%	Sunscreen
Zinc Oxide 11.8%	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. Works best on moisturized skin.
• Reapply:
  • After 80 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

Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Corallina Officinalis Extract, Methicone, Dimethicone, Laureth-4, Calcium Silicate, Triethoxycaprylylsilane, Sodium Sulfate, 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

Manufactured by Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

colorescience®

loose mineral sunscreen

SPF 30
sunforgettable®

Broad Spectrum SPF 30
Water Resistant (80 minutes)

Net Wt. 6 g / 0.21 oz

SUNFORGETTABLE LOOSE MINERAL SUNSCREEN SPF 30 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	210 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: 68078-001-02	1 in 1 CARTON	10/05/2015	10/06/2018
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	10/05/2015	10/06/2018

Labeler - Colorescience (128731929)

Revised: 7/2019

Document Id: a63f8194-4ebd-4ca6-ad7b-4bfbe87ac443

34390-5

Set id: 3a319a34-3130-43b4-8ceb-154126b8dee3

Version: 2

Effective Time: 20190701

 

Colorescience