Sunforgettable® Lip Shine SPF 35 Sunscreen

Drug Labeling and Warnings

Drug Details [pdf]

SUNFORGETTABLE LIP SHINE SPF 35 SUNSCREEN- zinc oxide liquid 
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.

----------

Sunforgettable® Lip Shine SPF 35 Sunscreen

Drug Facts

Active ingredients

Zinc Oxide 5%

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.

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

Phenyl Trimethicone, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Palmitoyl Oligopeptide, Ethylhexyl Palmitate, Tribehenin, Sorbitan Isostearate, Mentha Viridis (Spearmint) Leaf Oil, Glyceryl Isostearate, Polyhydroxystearic Acid, Cetyl Dimethicone, Mica, Silica, Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891), Carmine (CI 75470). Contains carmine as a color additive.

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 - 3.5 mL Tube Carton

colorescience®

lip shine

SPF 35
sunforgettable®

Broad Spectrum SPF 35
sunscreen
Water Resistant
(40 minutes)

3.5 mL / 0.12 Fl oz

SUNFORGETTABLE LIP SHINE SPF 35 SUNSCREEN 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Tricaprin (UNII: O1PB8EU98M)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Ethylhexyl Palmitate (UNII: 2865993309)
Glyceryl Isostearate (UNII: HYE7O27HAO)
Tribehenin (UNII: 8OC9U7TQZ0)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Spearmint Oil (UNII: C3M81465G5)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Palmitoyl Hexapeptide-12 (UNII: HO4ZT5S86C)
Bismuth Oxychloride (UNII: 4ZR792I587)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-012-13	1 in 1 CARTON	10/05/2015	04/30/2019
1		3.5 mL 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	04/30/2019

Labeler - Colorescience (128731929)

Revised: 7/2019

Document Id: dedd0e0a-1373-44c2-822d-0357f7489883

34390-5

Set id: 5904c010-a6fc-4745-8c62-0b3a9e5e253e

Version: 2

Effective Time: 20190701