CHANTECAILLE ULTRA SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 45- avobenzone, octinoxate, octisalate, octocrylene lotion

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45 by

Drug Labeling and Warnings

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45 by is a Otc medication manufactured, distributed, or labeled by Chantecaille Beaute Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45

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

Package labeling

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45

40ml 1.3 fl oz

FOR REFERENCE ONLY:

INGREDIENTS AND APPEARANCE

CHANTECAILLE ULTRA SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 45 
avobenzone, octinoxate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42893-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42893-013-00	40 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/30/2014

Labeler - Chantecaille Beaute Inc (095270166)