PREVENTION DAILY TINTED MOSITURIZER OIL-FREE TINTED 30- zinc oxide and titanium dioxide cream

Prevention daily tinted mositurizer oil-free Tinted 30 by

Drug Labeling and Warnings

Prevention daily tinted mositurizer oil-free Tinted 30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:
Zinc Oxide - 6.0%
Titanium Dioxide 4.6%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• To help protect the skin from harmful UVA and UVB rays.
• If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn.
  

WARNINGS

Warnings

For External Use Only

WHEN USING

• Keep out of eyes. If contact occurs rinse with water.

• Discontinue use of irritation or redness occurs

STOP USE

if severe skin irritation develops

KEEP OUT OF REACH OF CHILDREN

if swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Directions

• Apply to cleansed skin every morning as daily moisturizer and for ultimate protection
• Re-apply every 2 hours when exposed to sun or as needed
  

INACTIVE INGREDIENT

Aqua, Cyclopentasiloxane, Plankton Extract, Hexyl Triethoxysilylethyl, Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Dimethicone/PEG-10/15 Crosspolymer, Arabidopsis Extract, Dimethicone/Polyglycerin -3 Crosspolymer, Aluminum Hydroxide Stearic Acid, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Sodium Chloride, Cetearyl Olivate, Tetrahexyldecyl Ascorbate, Micrococcus Lysate, Lecithin, Tocopheryl Acetate, Caprylyl Glycol, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Iron Oxide (CI77491, CI77492, CI77499)

PRINCIPAL DISPLAY PANEL

Image International Palm Beach, FL 33462 USA www.imageskincare.com

INGREDIENTS AND APPEARANCE

PREVENTION DAILY TINTED MOSITURIZER OIL-FREE TINTED 30 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	46 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4067-2	1 in 1 CARTON
1	NDC: 62742-4067-1	91 g in 1 TUBE
2	NDC: 62742-4067-3	170 g in 1 TUBE
3	NDC: 62742-4067-4	7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/09/2014

Labeler - Allure Labs, Inc (926831603)