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3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 24.8mg in 1mL, ZINC OXIDE 60mg in 1mL
Labeler: 3LAB, Inc
NDC Code: 76159-234

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.

3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum

3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum


TITANIUM DIOXIDE 2.48%
ZINC OXIDE 6.00%

Active Ingredients


TITANIUM DIOXIDE 2.48%
ZINC OXIDE 6.00%

Purpose

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

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.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Apply to all skin exposed to the sun

Other InformationProtect this product from excessive heat and direct sun

Inactive IngredientsWater (Aqua/Eau), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Panthenol, Allantoin, Disodium EDTA, Lauryl PEG-9 Polydiemthylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin.

PERFECT Lite Sunscreen SPF 30 Clinically proven, this advanced physical sunscreen goes on smooth, clean and light to defend the skin against harmful UV rays. Containing ingredients found in nature, it is oil, PABA and fragrance-free - ideal for all skin types including sensitive skin. Micronized Titanium Dioxide and Zinc Oxide work immediately to help prevent the harmful effects of the sun including sunburn, skin damage, freckling and discoloration. Also helps prevent heat buildup on skin. Just Perfect!


3LAB PERFECT LITE SUNSCREEN SPF 30 BROAD SPECTRUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76159-234
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE24.8 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ETHYLHEXYL PALMITATE 
CYCLOMETHICONE 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
ALKYL (C12-15) BENZOATE 
POLYSORBATE 80 
ISOHEXADECANE 
CETYL ALCOHOL 
PROPYLENE GLYCOL 
TRIETHOXYCAPRYLYLSILANE 
ALOE VERA LEAF 
PANTHENOL 
ALLANTOIN 
EDETATE DISODIUM 
BUTYLENE GLYCOL 
CHAMOMILE 
GREEN TEA LEAF 
ALUMINUM OXIDE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
CHLORPHENESIN 
Packaging
#Item CodePackage Description
1NDC:76159-234-01100 mL in 1 TUBE
2NDC:76159-234-0210 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/2011
Labeler - 3LAB, Inc (162333277)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture(76159-234)

Revised: 12/2012
 
3LAB, 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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