Vertra Elemental Resistance Mick Fanning Signature SPF 28

Dosage form: stick
Ingredients: OCTINOXATE 5g in 100g, OCTOCRYLENE 5g in 100g, TITANIUM DIOXIDE 3g in 100g
Labeler: Vertra, Inc
NDC Code: 43458-1005

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.

Vertra Elemental Resistance Mick Fanning Signature Stick SPF 28

Vertra Elemental Resistance Mick Fanning Signature Stick SPF 28


Active Ingredients

                                

OCTINOXATE 5%

OCTOCRYLENE 5%

TITANIUM DIOXIDE 3%


Uses
  • Helps prevent sunburn  
  • For skin highly sensitive to sunburn  
  • Retains SPF after 80 minutes of activity in water

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, NOT skin cancer or early skin aging.

Warnings:

  • For external use only

When using this product
  • Keep out of eyes.  Rinse with water to remove.

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:
  • Apply liberally 15 minutes before sun exposure. Blend into skin with finger or applicator if necessary.

  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Children under 6 months of age: ask a doctor

Sun Protections 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 of 15 or higher and other sun protection measure including:
    • limit time in the sun especially from 10am to 2pm
    • wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

ALUMINUM HYDROXIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLENE/PROPYLENE COPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HEXYLDECYL ISOSTEARATE, OZOKERITE, PARAFFIN, POLYGLYCERYL-2, TRIISOSTEARATE, SILICA, STEARIC ACID, SYNTHETIC WAX, TOCOPHEROL

Purpose

Sunscreen

Description

This face stick is a collaboration between 2-time World Surfing Champion Mick Fanning and Vertra. Mick takes his skin protection as seriously as he does his competition. For his signature stick he chose to develop a product that was void of pigments and fragrance but yet still provided the necessary protection needed for long days at event venues, warm-up sessions and competitive heats.

  • Water Resistant (80 minutes)
  • Fragrance Free
  • Smooth, non-greasy application

Vertra Elemental Resistance Mick Fanning Signature Stick SPF 28 Listing 9.5g/.34oz





VERTRA ELEMENTAL RESISTANCE MICK FANNING SIGNATURE SPF 28 
octinoxate, octocrylene, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43458-1005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE5 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
MEDIUM-CHAIN TRIGLYCERIDES 
TRIMETHYLOLPROPANE 
CERESIN 
PARAFFIN 
ISOSTEARIC ACID 
SILICON DIOXIDE 
STEARIC ACID 
SYNTHETIC WAX (1200 MW) 
TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:43458-1005-91 TUBE (TUBE) in 1 CARTON
19.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/08/2012
Labeler - Vertra, Inc (930280362)
Registrant - Toshiki Pigment Company Limited (690723812)
Establishment
NameAddressID/FEIOperations
Toshiki Pigment Company Limited690723812manufacture

Revised: 03/2012
 
Vertra, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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