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NDC 69749-0640-01 Vasseur Skincare Day Matte SPF30 60; 60 mg/g; mg/g Details

Vasseur Skincare Day Matte SPF30 60; 60 mg/g; mg/g

Vasseur Skincare Day Matte SPF30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Vasseur International Inc. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	69749-0640
Product ID	69749-640_482e2384-ef1a-01c7-e054-00144ff88e88
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	Vasseur Skincare Day Matte SPF30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	60; 60
Active Ingredient Units	mg/g; mg/g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Vasseur International Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69749-0640-01 (69749064001)

Pricing Information	N/A
NDC Package Code	69749-640-01
Billing NDC	69749064001
Package	113 g in 1 BOTTLE (69749-640-01)
Marketing Start Date	2017-02-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b805f352-60b2-409f-ab97-5cc151a66e9e Details

Drug Facts

Active Ingredients

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Sunscreen

Uses:

Helps prevent sunburn.
If used as directed with other sun protection measure (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 consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

Apply liberally 15-minutes before sun exposure.

Reapply:

• At least every two-hours.

• Immediately after swimming, sweating or towel drying.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

• Limit time in the sun, especially between 10am and 2pm.

• Wear long sleeve shirts, pants, hats and sunglasses.

• For children under 6-months, consult a physician.

Other Ingredients:

ALOE BARADENSIS LEAF (ALOE VERA GEL) JUICE, AQUA (DELONIZED WATER), CAMELLIA SINENSIS (GREEN TEA) EXTRACT, ETHYLHEXYLGLYCERIN, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) OIL, LECITHIN, OCTYL PALMITATE, PHENOXYETHANOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SESAMUM INDICUM (SESAME) SEED OIL, SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE, THEOBROMA CACAO (COCOA) BUTTER, TOCOPHEROL (VITAMIN E), XANTHAN GUM

Product Label

INGREDIENTS AND APPEARANCE

VASSEUR SKINCARE DAY MATTE SPF30

titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69749-640
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALMOND OIL (UNII: 66YXD4DKO9)
SESAME OIL (UNII: QX10HYY4QV)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69749-640-01	113 g in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/07/2015

Labeler - Vasseur International Inc (150096316)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(69749-640)

Revised: 2/2017

Document Id: 482e2384-ef1a-01c7-e054-00144ff88e88

Set id: b805f352-60b2-409f-ab97-5cc151a66e9e

Version: 3

Effective Time: 20170210