CHANTECAILLE ULTRA SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, octinoxate, octisalate and octocrylene lotion 
Chantecaille Beaute Inc

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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CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 30

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 30

ACTIVE INGREDIENTS

AVOBENZONE 3%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 2.75%

PURPOSE

SUNSCREEN

USE

  • 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 EXTERNALS USE ONLY

DO NOT USE On damages 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 Poison Control Center right away.


DIRECTIONS

  • Apply liberally 15 minutes before sun exposure
  • Immediately after towel drying
  • At least every 2 hours
  • 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
    • Children under 6 months of age: Ask a doctor

OTHER INFORMATION

  • Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENTS:

C12-15 ALKYL BENZOATE, DAMASK ROSE (ROSA DAMASCENA) FLOWER WATER, BUTYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, POLYMETHYL METHACRYLATE, ISONONYL ISONONANOATE, METHYL METHACRYLATE CROSSPOLYMER, GLYCERIN, VINYL DIMETHICONE/METHICONE, SILSESQUIOXANE CROSSPOLYMER, DICAPRYLYL CARBONATE, PENTYLENE GLYCOL, POLYGLYCERYL-6 POLYRICINOLEATE, PHENOXYETHANOL, SODIUM CHLORIDE, POLYGLYCERYL-2 ISOSTEARATE, TETRASODIUM EDTA, TOCOPHEROL, LEMON BALM (MELISSA OFFICINALIS) LEAF EXTRACT, STEARYL GLYCYRRHETINATE, CARNOSINE, LECITHIN, TEA (CAMELLIA SINENSIS) LEAF EXTRACT, YOSHINO CHERRY (PRUNUS YEDOENSIS) LEAF EXTRACT, CYCLODEXTRIN

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 30 40ml (42893-012-00)

UltraSunBox
CHANTECAILLE ULTRA SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, octinoxate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42893-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TOCOPHEROL (UNII: R0ZB2556P8)  
OCIMUM AFRICANUM LEAF (UNII: 0231102WJO)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
CARNOSINE (UNII: 8HO6PVN24W)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
TEA LEAF (UNII: GH42T47V24)  
PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42893-012-0040 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/30/201401/08/2016
Labeler - Chantecaille Beaute Inc (095270166)

Revised: 1/2016
 
Chantecaille Beaute Inc