SUNTEGRITY LIP CPR LIPSTICK SUNRISE PEACH SPF30- zinc oxide lipstick 
Synchronicity Spa, Inc dba Suntegrity

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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Suntegrity Lip C.P.R SPF 30 Sunrise Peach

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)

SunrisePeach

SUNTEGRITY LIP CPR LIPSTICK SUNRISE PEACH  SPF30
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69949-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69949-300-021 in 1 CARTON12/15/2015
1NDC:69949-300-012.8 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/15/201512/08/2020
Labeler - Synchronicity Spa, Inc dba Suntegrity (079164130)

Revised: 12/2020
 
Synchronicity Spa, Inc dba Suntegrity