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NDC 42893-0011-00 CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 10.157 g/100g Details

CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 10.157 g/100g

CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Chantecaille Beaute Inc. The primary component is TITANIUM DIOXIDE.

Product Information

NDC	42893-0011
Product ID	42893-011_d22c67dd-b8d7-b8bd-e053-2995a90a2041
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15
Proprietary Name Suffix	n/a
Non-Proprietary Name	TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10.157
Active Ingredient Units	g/100g
Substance Name	TITANIUM DIOXIDE
Labeler Name	Chantecaille Beaute Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 42893-0011-00 (42893001100)

Pricing Information	N/A
NDC Package Code	42893-011-00
Billing NDC	42893001100
Package	50 g in 1 TUBE (42893-011-00)
Marketing Start Date	2014-07-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 20b2d20f-9611-4481-bd6b-df95bf4bcc82 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Chantecaille Beaute Inc (095270166)

Registrant - Chantecaille Beaute Inc (095270166)

Revised: 12/2021

Document Id: d22c67dd-b8d7-b8bd-e053-2995a90a2041

Set id: 20b2d20f-9611-4481-bd6b-df95bf4bcc82

Version: 6

Effective Time: 20211202