Patricks Sunscreen

Dosage form: lotion
Ingredients: Avobenzone 2g in 100g, Octinoxate 7.25g in 100g, Octocrylene 9.75g in 100g, Oxybenzone 3g in 100g
Labeler: O.P. Products, Inc.
NDC Code: 40061-990

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.

Active ingredients.............

Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%

Uses
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • High protection against sunburn and tanning
  • Retains SPF after 40 minutes of activity in the water or sweating

Warnings
  • For external use only. When using this product
  • Keep out of eyes
  • Rinse with warm water to remove.  Stop use and ask doctor if
  • rash or irritation develops and lasts

Directions
  • Apply liberally 30 minutes before sun exposure
  • Children under 6 months of age consult a doctor
  • Reapply as needed or after towel drying, swimming or sweating

Purpose

Purpose...............Sunscreen

  • Keep out of reach of children.

Inactive ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Acrylates/C12-22 Alkyl Methacrylate Copolymer (Waterproofing), Aloe Barbadensis (Aloe Vera) Leaf Juice, Isododecane, Phenoxyethanol (Preservative), Fragrance (Parfum), Tetrasodium EDTA, Carbomer, Triethanolamine, Sorbitan Oleate (Plant Derived), Tocopheryl Acetate (Vitamin E Acetate), Retinyl Palmitate (Vitamin A Palmitate), Cereus Grandiflorus (Cactus) Flower Extract, Methylisothiazolinone.

Questions or comments: 1-800-411-8801 . patrickssunscreen.com

Place holder text.

PATRICKS SUNSCREEN 
avobenzone, octinoxate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40061-990
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone2 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.25 g  in 100 g
Octocrylene (Octocrylene) Octocrylene9.75 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Alkyl (C12-15) Benzoate 
Aloe Vera Leaf 
Isododecane 
Phenoxyethanol 
Edetate Sodium 
Carbomer Copolymer Type A 
Trolamine 
Sorbitan Monooleate 
Alpha-Tocopherol Acetate 
Vitamin A Palmitate 
Selenicereus Grandiflorus Flower 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:40061-990-088 PACKET (PACKET) in 1 CELLO PACK
1NDC:40061-990-108.75 g in 1 PACKET
2NDC:40061-990-5050 PACKET (PACKET) in 1 BOX
2NDC:40061-990-108.75 g in 1 PACKET
3NDC:40061-990-118.75 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/28/2011
Labeler - O.P. Products, Inc. (840571231)
Establishment
NameAddressID/FEIOperations
O.P. Products, Inc.840571231relabel
Establishment
NameAddressID/FEIOperations
G.A.R. Laboratories, Inc.074933615manufacture
Establishment
NameAddressID/FEIOperations
LICO Industries, LLC098009041repack

Revised: 01/2012
 
O.P. Products, 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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