SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20- zinc oxide, octinoxate lotion 
Isomers Laboratories Inc

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.

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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.

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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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide80 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Polysorbate 60 (UNII: CAL22UVI4M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Chlorphenesin (UNII: I670DAL4SZ)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Panthenol (UNII: WV9CM0O67Z)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MINERAL OIL (UNII: T5L8T28FGP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64990-885-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/06/201912/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/31/200312/22/2022
Labeler - Isomers Laboratories Inc (253306799)
Registrant - Isomers Laboratories Inc (253306799)
Establishment
NameAddressID/FEIBusiness Operations
Isomers laboratories Inc253306799manufacture(64990-885)

Revised: 12/2022
 
Isomers Laboratories Inc