SUNFORGETTABLE TOTAL PROTECTION BRUSH-ON SHIELD SPF 50- titanium dioxide and zinc oxide powder

Sunforgettable Total Protection Brush-On Shield SPF 50 by

Drug Labeling and Warnings

Sunforgettable Total Protection Brush-On Shield SPF 50 by is a Otc medication manufactured, distributed, or labeled by Colorescience. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 22.5%	Sunscreen
Zinc Oxide 22.5%	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, Dimethiconol/Propylsilsequioxane/Silicate Crosspolymer, Lycopodium Clavatum Extract, Sodium Hyaluronate, Imperata Cyclindrica Root Extract, Glycerin, Water, Caesalpinia Spinosa Fruit Pod Extract, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis Leaf Extract, Quercus Robur (Oak) Wood Extract, Helianthus Annuus (Sunflower) Sprout Extract, Maltodextrin, Methicone, Triethoxycaprylylsilane, Laureth-4, Sodium Benzoate, Potassium Sorbate, Chromium Oxide Greens (CI 77288), Iron Oxides (CI77491, CI 77492, CI 77499)

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 866.426.5673

SPL UNCLASSIFIED SECTION

Distributed in USA by
colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 2 g Tube Carton

colorescience®

SUNFORGETTABLE®
TOTAL PROTECTION™

BRUSH-ON SHIELD MINI SIZE

• + Protects from: UVA/UVB,
  pollution, blue light, IR
• + Hydrating, antioxidant-rich
• + Use alone or over makeup

50
Broad Spectrum
SPF 50 Sunscreen
PA++++

CHEMICAL-FREE ACTIVES | 100% MINERAL
WATER/SWEAT RESISTANT (80 MINUTES)

Net Wt. 2 g / 0.07 oz.

OPEN

INGREDIENTS AND APPEARANCE

SUNFORGETTABLE TOTAL PROTECTION BRUSH-ON SHIELD SPF 50 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	225 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	225 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Dimethicone/Vinyl Dimethicone Crosspolymer (Hard Particle) (UNII: H895X08VNQ)
Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer (450000000 MW) (UNII: 9KB5R958PB)
Maltodextrin (UNII: 7CVR7L4A2D)
Methicone (20 CST) (UNII: 6777U11MKT)
Glycerin (UNII: PDC6A3C0OX)
Laureth-4 (UNII: 6HQ855798J)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Imperata Cylindrica Root (UNII: VYT2JA85NH)
Water (UNII: 059QF0KO0R)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Vitis Vinifera Seed (UNII: C34U15ICXA)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Quercus Robur Twig Bark (UNII: 2JFK226947)
Caesalpinia Spinosa Resin (UNII: WL3883U2PO)
Sunflower Oil (UNII: 3W1JG795YI)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Ferric Oxide Red (UNII: 1K09F3G675)
Chromic Oxide (UNII: X5Z09SU859)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-027-01	1 in 1 CARTON	04/01/2018
1		6 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 68078-027-02	2 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/31/2018

Labeler - Colorescience (128731929)