SUNTEGRITY LIP CPR LIPSTICK SABLE SHADE SPF30- zinc oxide lipstick

Suntegrity Lip CPR Lipstick Sable Shade by

Drug Labeling and Warnings

Suntegrity Lip CPR Lipstick Sable Shade by is a Otc medication manufactured, distributed, or labeled by Synchronicity Spa, Inc dba Suntegrity. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide - 18%

Purpose

Sunscreen

Uses

• Helps preent sunburn
• if used as directed wtih other sun protection measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs

When using this product

keep out of eyes.  Rinse with water to remove.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For Sunscreen use:

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours.
• Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin ageing.  To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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
• Children under 6 months: Ask a doctor.

Inactive Ingredients

Persea Gratissima (Avocado) Oil,Caprylic/Capric Triglyceride, Vitis Vinifera (Grape) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Vegetable Oil, Polyglycerol Polyricinoleate, Mica, Ethylhexyl Palmitate, Phytosteryl Canola Glycerides, Ricinus Communis (Castor) Oil, Phospholipids, Polyglyceryl-3 Diiostearate, Tocopheryl Acetate, Sodium Hyaluronate, Trihydroxystearin, Silica, Amorphophallus Konjac Root Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Hippophae Rhamnoides Extract, Helianthus Annuus (Sunflower) Seed Oil, Stevia Rebaudiana Leaf/Stem Powder, May Contain (+/-): Iron Oxides (CI 77491), Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxide (CI 77492), Iron Oxide(CI77499)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNTEGRITY LIP CPR LIPSTICK SABLE SHADE  SPF30
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69949-293
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AVOCADO OIL (UNII: 6VNO72PFC1)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)
CANDELILLA WAX (UNII: WL0328HX19)
OLEIC ACID (UNII: 2UMI9U37CP)
POLYGLYCEROL POLYRICINOLEIC ACID (UNII: 3C96Y1D5T4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CANOLA OIL (UNII: 331KBJ17RK)
CASTOR OIL (UNII: D5340Y2I9G)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
HIPPOPHAE RHAMNOIDES FRUIT JUICE (UNII: UC3P08EB3Y)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69949-293-02	1 in 1 CARTON	12/15/2015
1	NDC: 69949-293-01	2.8 g in 1 CYLINDER; 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	12/15/2015

Labeler - Synchronicity Spa, Inc dba Suntegrity (079164130)