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Ocean Potion Moisturizing Lip Potion 45

Dosage form: lipstick
Ingredients: OCTINOXATE 7.5g in 100g, OCTISALATE 5g in 100g, OXYBENZONE 5.0g in 100g, OCTOCRYLENE 5.0g in 100g, AVOBENZONE 2g in 100g
Labeler: Sun & Skin Care Research, LLC
NDC Code: 62802-085

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 Ingredients
Avobenzone: 2%
Octinoxate: 7%
Octisalate: 5%
Octocrylene: 5%
Oxybenzone: 5%


Purpose

Sunscreen

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • temporarily protects lips from the drying effects of wind and cold weather

Warnings

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 contact a Poison Control Center right away.

Directions
  • apply liberally before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • store at room temperature

Other Information
  • For use on skin only
  • Avoid contact with fabric
  • Protect this product from excessive heat and direct sun



OCEAN POTION MOISTURIZING LIP POTION 45 
avobenzone, octisalate, octocrylene, oxybenzone, octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-085
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 5.0 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE5.0 g  in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
COCONUT OIL 
CARNAUBA WAX 
CANDELILLA WAX 
CORN OIL 
MINERAL OIL 
MYRISTYL LACTATE 
CERESIN 
PETROLATUM 
PROPYLPARABEN 
SACCHARIN 
Packaging
#Item CodePackage Description
1NDC:62802-085-014.4 g in 1 CONTAINER
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
Document Id: d60a9658-b052-46af-8a13-f864b9fa36e5
Set id: 1928f12e-2064-4ac2-bc24-79c2e8eb6e4e
Version: 2
Effective Time: 20120518
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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