FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE VERTRA- 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 SPF 35 Stick Foundation - Cooly Beige

Active Ingredients                     Purpose

Titanium Dioxide 23%           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
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes activity in the water, sweating, or perspiring.
  • Provides high protection against sunburn

Keep out of reach of chilcren. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • apply to all skin exposed to sun
  • use a water resistant sunscreen if swimming or sweating
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at leasty every 2 hours
  • 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: ask a doctor

Hexyldecyl Isostearate, 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 35
Water Resistant (80 minutes)

Color: Cooly Beige

11g NET WT. .39 OZ.

cooley beige Fanning face stick SPF 35 update

cooley beige Fanning face stick SPF 35 update stick

FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE  VERTRA
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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:71014-010-021 in 1 BOX10/07/201603/01/2022
1NDC:71014-010-0111 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/07/201603/01/2022
Labeler - Eai-Jr286, Inc. (827896718)
Establishment
NameAddressID/FEIBusiness Operations
Toshiki Pigment Co., ltd.716140285manufacture(71014-010)

Revised: 11/2022
 
Eai-Jr286, Inc.