Dermectin Sunscreen Broad Spectrum SPF 30

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 71uL in 1mL
Labeler: PureTek Corporation
NDC Code: 59088-942

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.

Drug Facts

Active ingredient

Titanium dioxide 7.1%

Purpose

Sunscreen

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • moderate protection against sunburn

Warnings

For external use only

Do not use
  • on broken or damaged skin

When using this product
  • keep out of eyes
  • rinse with water to remove

Stop use and ask a doctor if
  • skin rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Central right away.

Directions
  • for sunscreen use
  • apply liberally and evenly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply
    • after 40 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 SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses

  • children under 6 months of age: Ask a doctor

other information
  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

purified water, cyclopentasiloxane, octyldodecyl neopentanoate, pentylene glycol, butylene glycol, stearic acid, dicaprylyl carbonate, polyglyceryl-3 polydimethylsiloxyethyl dimethicone, helianthus annuus (sunflower) seed oil unsaponifiables, butyrospermum parkii (shea butter), dimethicone crosspolymer, dimethicone, glyceryl stearate, PEG-100 stearate, C20-22 alkyl phosphate, stearyl dimethicone, C20-22 alcohols, magnesium aluminum silicate, dimethicone/PEG-10/15 crosspolymer, hydrogenated lecithin, cetearyl alcohol, polysorbate 60, triethanolamine, camellia sinensis leaf extract (white tea and oolong tea), camellia oleifera (green tea) seed extract, chlorphenesin,  panthenol, xanthan gum, sodium ascorbyl phosphate, tocopheryl acetate, tetrahexyldecyl ascorbate, dipotassium glycyrrhizate, aluminum hydroxide.

Questions or Comments:

877-921-7873

Carton

DERMECTIN SUNSCREEN  BROAD SPECTRUM SPF 30
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-942
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE71 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
BUTYLENE GLYCOL 
SHEA BUTTER 
C20-22 ALCOHOLS 
C20-22 ALKYL PHOSPHATE 
CAMELLIA OLEIFERA SEED 
GREEN TEA LEAF 
CETOSTEARYL ALCOHOL 
CHLORPHENESIN 
CYCLOMETHICONE 5 
DICAPRYLYL CARBONATE 
DIMETHICONE 
GLYCYRRHIZINATE DIPOTASSIUM 
GLYCERYL MONOSTEARATE 
SUNFLOWER OIL 
HYDROGENATED SOYBEAN LECITHIN 
MAGNESIUM ALUMINUM SILICATE 
OCTYLDODECYL NEOPENTANOATE 
PANTHENOL 
PEG-100 STEARATE 
PENTYLENE GLYCOL 
POLYSORBATE 60 
WATER 
SODIUM ASCORBYL PHOSPHATE 
STEARIC ACID 
TETRAHEXYLDECYL ASCORBATE 
ALPHA-TOCOPHEROL ACETATE 
TROLAMINE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:59088-942-081 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/12/2011
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIOperations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 07/2011
 
PureTek Corporation

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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