3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum

Dosage form: cream
Ingredients: HOMOSALATE 100mg in 1mL, OCTISALATE 50mg in 1mL, AVOBENZONE 30mg in 1mL, OCTOCRYLENE 26mg in 1mL
Labeler: 3LAB, Inc
NDC Code: 76159-345

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 Sunscreen SPF 50+ Broad Spectrum

Active Ingredients

Homosalate 10.0% Octisalate 5.0% Avobenzone 3.0% Octocrylene 2.6%

Purpose

Sunscreen

Uses

Helps prevent sunburn

If used ad 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 Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water (Aqua/Eau), Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/ PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-15, Polyacrylate-17, Alcohol, Butylene Glycol, Adenosine, Euterpa Oleracea (Acai) Fruit Extract, Portulaca Oleracea Extract, Morus Alba (Mulberry) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Dipotassium Glycyrrhizate, Glyceryl Stearate, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Panthenol, Cetyl Alcohol, Caprylyl Glycol, Tocopheryl Acetate, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Potassium Hydroxide, Disodium EDTA

This ultimate sun protection cream was created for those who desire a maximum defense against UVA and UVB rays while fighting free radical damage. Using a unique, lightweight formula with special polymer technology, this sunblock helps to prevent sun damage without feeling heavy on the skin. The powerful antioxidants, green tea and acai berry, work to combat the signs of premature aging, such as sun spots and wrinkles, while Vitamin E soothes and hydrates sun exposed skin. 


3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM 
homosalate, octisalate, avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76159-345
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE100 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE26 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIPROPYLENE GLYCOL 
DICAPRYLYL CARBONATE 
POTASSIUM CETYL PHOSPHATE 
HYDROGENATED PALM GLYCERIDES 
ALCOHOL 
BUTYLENE GLYCOL 
ADENOSINE 
GREEN TEA LEAF 
GLYCYRRHIZINATE DIPOTASSIUM 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
ISOHEXADECANE 
POLYSORBATE 80 
PANTHENOL 
CETYL ALCOHOL 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
POTASSIUM HYDROXIDE 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:76159-345-0160 mL in 1 TUBE
2NDC:76159-345-0210 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/21/2011
Labeler - 3LAB, Inc (162333277)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture(76159-345)

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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