LIP SHINE SPF35 SUNSCREEN- zinc oxide liquid

Lip Shine SPF35 Sunscreen by

Drug Labeling and Warnings

Lip Shine SPF35 Sunscreen 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 ingredients

Zinc Oxide 6.6%

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: 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, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Mica, Ethylhexyl Palmitate, Tocopheryl Acetate, Triethyl Citrate, Glyceryl Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic Acid, Tribehenin, Sodium Hyaluronate, Palmitoyl Tripeptide-1, Sorbitan Isostearate, Tin Oxide, Flavor/Aroma, Limonene, 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

SPL UNCLASSIFIED SECTION

Distributed in USA
by Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 4 mL Tube Carton

colorescience®

LIP
SHINE

Moisturizes & smooths lips

Defends against UV rays

Tint of color, natural shine

Water resistant
(40 minutes)

35

Broad Spectrum
SPF 35
Sunscreen

0.13 fl. oz. / 4 mL

INGREDIENTS AND APPEARANCE

LIP SHINE SPF35 SUNSCREEN 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	66 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)
Disteardimonium Hectorite (UNII: X687XDK09L)
MICA (UNII: V8A1AW0880)
Ethylhexyl Palmitate (UNII: 2865993309)
Triethyl Citrate (UNII: 8Z96QXD6UM)
Glyceryl Isostearate (UNII: HYE7O27HAO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Tribehenin (UNII: 8OC9U7TQZ0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
STANNIC OXIDE (UNII: KM7N50LOS6)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CARMINIC ACID (UNII: CID8Z8N95N)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-028-01	1 in 1 CARTON	07/01/2017
1		4 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 68078-028-02	1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	07/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/01/2017

Labeler - Colorescience (128731929)