FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD VERTRA- titanium dioxide stick 
Eai-jr 286, 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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Shane Dorian Foundation Sunscreen Broad Spectrum SPF 38 Kona Gold

   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

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

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

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 least 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 value 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2p.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 Oxide(CI 77491), Iron Oxide(CI 77492), Iron Oxide(CI 77499)

Vertra Elemental Resistance

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 38

Water Resistant (80 minutes)

Color Kona Gold

11g Net Wt. .39 oz

Kona Gold Shane Face stick 38 art update

Kona Gold Shane Face stick 38 stick art update

FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD  VERTRA
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-011
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71014-011-021 in 1 BOX04/02/201803/01/2022
1NDC:71014-011-0111 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/02/201803/01/2022
Labeler - Eai-jr 286, Inc (827896718)
Registrant - Eai-jr 286, Inc (827896718)
Establishment
NameAddressID/FEIBusiness Operations
Toshiki Pigment Co., Ltd716140285manufacture(71014-011)

Revised: 11/2022
 
Eai-jr 286, Inc