Isomers Sunscreen with UV pearls Broad Spectrm SPF 20

Dosage form: lotion
Ingredients: Zinc Oxide 80mg in 1mL, Octinoxate 75mg in 1mL
Labeler: Isomers Laboratories Inc
NDC Code: 64990-885

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

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Active Ingredients:

Zinc Oxide                           8.0%

Octyl Methoxycinnamate      7.5%

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Purpose

Sunscreen

  • helps prevent sunburn
  • if used as directed with other sun protection measures (See Direction ),decreases the risk of skin cancer and early skin aging caused by the sun.

  • For external use only
  • When using this product, keep out of eyes.Rinse with watewr to remove.

Do Not Use on damaged or broken skin

Stop use and ask a doctor if rash occurs.

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  • Keep out of reach of children
  • If product is swallowed get medical help or contact the Poison Control Center right away.

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Inactive Ingredients:

Purified Water, Cetearyl Alcohol, Phenyl Trimethicone, Caprylic/Capric Triglyceride, Propylen Glycol, Ceteareth-20, Polyhydroxystearic Acid, Mineral Oil, Panthenol, Silica, PVP, Chlorphenesin, Tocopheryl Acetate, Aloe Barbadensis Leaf extract, Polysorbate 60, BHT, Phenoxyethanol, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben.

  • Apply Liberally 15 minutes before sun exposure.
  • reapply at least every two hours
  • use a water -resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor.
  • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures.
  • Limit time in the sun especially from 10 a.m. to 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.

MM10

ISOMERS SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20 
zinc oxide, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-885
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (ZINC OXIDE) Zinc Oxide80 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cetostearyl Alcohol 
Polysorbate 60 
MEDIUM-CHAIN TRIGLYCERIDES 
Silicon Dioxide 
Chlorphenesin 
Butylated Hydroxytoluene 
Aloe Vera Leaf 
Panthenol 
Methylparaben 
Propylparaben 
Phenyl Trimethicone 
PROPYLENE GLYCOL 
POLYHYDROXYSTEARIC ACID (2300 MW) 
MINERAL OIL 
.ALPHA.-TOCOPHEROL ACETATE 
PHENOXYETHANOL 
MAGNESIUM DISODIUM EDTA 
UREA 
Packaging
#Item CodePackage Description
1NDC:64990-885-01120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/31/2003
Labeler - Isomers Laboratories Inc (253306799)
Registrant - Isomers Laboratories Inc (253306799)
Establishment
NameAddressID/FEIOperations
Isomers laboratories Inc253306799manufacture(64990-885)

Revised: 05/2013
 
Isomers Laboratories 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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