TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50 VERTRA- padimate o, titanium dioxide stick 
Eai-Jr286, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vertra Elemental Resistance Broad Spectrum Foundation Face Screen SPF 50 - Translucent

Active Ingredients                       Purpose

Padamite O 7%                             Sunscreen

Titanium Dioxide 17%

Uses

Keep out of reach of children. If products is swallowed, get medical help or contact Poison Control Center right away.

Stop use and ask a doctor if rash or irritation develops and lasts

Warnings

For external use only

Directions

Hexyldecyl Isosterate, Mica, Synthetic wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopheryl, Fragrance, Iron Oxides

Vertra Elemental Resistance

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 50+

Water Resistant (80 minutes)

Color: Translucent

10.5g  NET WT. .37 oz.

Translucent SPF 50 updated box

Translucent SPF 50 updated stick

TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50  VERTRA
padimate o, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE17.45 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)  
MICA (UNII: V8A1AW0880)  
CERESIN (UNII: Q1LS2UJO3A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71014-005-021 in 1 BOX10/07/2016
1NDC:71014-005-0110.5 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/07/2016
Labeler - Eai-Jr286, Inc. (827896718)
Registrant - Eai-Jr286, Inc. (827896718)
Establishment
NameAddressID/FEIBusiness Operations
Toshiki Pigment Co., ltd.716140285manufacture(71014-005)

Revised: 1/2020
Document Id: 4e8d80c2-ebb5-4d11-a19e-95d2cf33dae8
Set id: 944f02dc-7b02-4eca-aa2b-b6416cf7bb80
Version: 7
Effective Time: 20200108
 
Eai-Jr286, Inc.