OP Dark Formula Xtreme Tanning 4

Dosage form: lotion
Ingredients: OCTINOXATE 3mL in 100mL, OCTISALATE 2mL in 100mL
Labeler: Sun & Skin Care Research, LLC
NDC Code: 62802-600

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

Active IngredientsOctinoxate 3.0%
Octisalate 2.0%

Purpose

Sunscreen

Uses
  • Helps prevent sunburn

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.  Do not use on damaged or broken skin.  Stop use and ask a doctor if rash occurs.  When using this product keep out of eyes.  Rinse with water to remove.  Keep out of the reach of children.  If swallowed, get medical help or call a poison control center right away.

Directions
  • apply evenly and liberally to all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product.
  • reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
  • children under 6 months:  Ask a doctor

Other Information
  • protect this product from excessive heat and direct sun
  • for use on skin only
  • avoid contact with fabric

OP DARK FORMULA XTREME TANNING 4 
octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-600
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOMER HOMOPOLYMER TYPE C 
CARAMEL 
CANOLA OIL 
OLIVE OIL 
VITAMIN A PALMITATE 
ALPHA-TOCOPHEROL ACETATE 
SUNFLOWER OIL 
BUTYLPARABEN 
EDETATE DISODIUM 
ETHYLPARABEN 
GLYCERIN 
HYPROMELLOSE 2910 (4000 MPA.S) 
ISOBUTYLPARABEN 
METHYLPARABEN 
PHENOXYETHANOL 
POLYISOBUTYLENE (2300 MW) 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SORBITAN MONOOLEATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62802-600-08251 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2012
Labeler - Sun & Skin Care Research, LLC (849772207)
Establishment
NameAddressID/FEIOperations
Sun & Skin Care Research, LLC849772207manufacture

Revised: 05/2012
 
Sun & Skin Care Research, LLC

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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