CHANTECAILLE JUST SKIN TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15- titanium dioxide lotion

CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Chantecaille Beaute Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15

ACTIVE INGREDIENT

TITANIUM DIOXIDE 10.5157%

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 Poison Control Center right away.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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

WATER/AQUA/EAU, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, TALC, NEOPENTYL GLYCOL DIETHYLHEXANOATE, GLYCERIN, PEG-10 DIMETHICONE, DIMETHICONE, PHENYL TRIMETHICONE, PENTYLENE GLYCOL, MAGNESIUM SULFATE, PEG-400, ALUMINUM HYDROXIDE, STEARIC ACID, SILICA DIMETHYL SILYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, MICA, PHENOXYETHANOL, TRIMETHYLSILOXYSILICATE, DEXTRIN PALMITATE, TOCOPHEROL, ALUMINA, ALCOHOL DEN., DAMASK ROSE (ROSA DAMASCENA) FLOWER WATER, LEONTOPODIUM ALPINUM EXTRACT, THYMUS VULGARIS (THYME) FLOWER/LEAF EXTRACT, BUDDLEJA DAVIDII EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, ALGAE EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, SUPEROXIDE DISMUTASE, SODIUM DEXTRAN SULFATE, GLYCINE SOJA (SOYBEAN) PROTEIN, SODIUM BENZOATE, ETHYLHEXYLGLYCERIN, POTASSIUM SORBATE, TITANIUM DIOXIDE, IRON OXIDES

CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 50g (

42893-011-00)

INGREDIENTS AND APPEARANCE

CHANTECAILLE JUST SKIN TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42893-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.157 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TOCOPHEROL (UNII: R0ZB2556P8)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
ROSA DAMASCENA WHOLE (UNII: 3I09LG9MVL)
LEONTOPODIUM NIVALE SUBSP. ALPINUM WHOLE FLOWERING (UNII: 7R4LQP52DM)
THYME (UNII: CW657OBU4N)
BUDDLEJA DAVIDII WHOLE (UNII: 8JZ8B2V1OV)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
SOYBEAN (UNII: L7HT8F1ZOD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42893-011-00	50 g in 1 TUBE; Type 0: Not a Combination Product	07/17/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/17/2014

Labeler - Chantecaille Beaute Inc (095270166)

Registrant - Chantecaille Beaute Inc (095270166)