OCEAN POTION INSTANT DRY 50 MIST SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Ocean Potion Instant Dry 50 Mist Sunscreen by

Drug Labeling and Warnings

Ocean Potion Instant Dry 50 Mist Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sun & Skin Care Research, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate: 15%
Octisalate: 5%
Octocrylene: 7%
Avobenzone: 3%

Purpose

Sunscreen

Uses

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

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 away from face to avoid breathing in.  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.  Flammable  Do not use near heat, flame or while smoking.  Avoid long term storage above 104°F (40°C).  Avoid spraying in eyes.  Contents under pressure.  Do not puncture or incinerate.  Do not store in temperatures above 120°F.

Directions

• spray evenly and liberally on all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product
• hold can 4-6 inches away from the skin to apply
• do not spray directly on face.  Spray on hands then apply to face
• do not apply in windy conditions.  Use in a well-ventilated area
  
• reapply after 80 minutes of swimming or sweating and immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants hats and sunglasses.
• children under 6 months: Ask a doctor
  

Other Information

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OCEAN POTION INSTANT DRY 50 MIST SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62802-647
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62802-647-06	177 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2012

Labeler - Sun & Skin Care Research, LLC (849772207)

Establishment
Name	Address	ID/FEI	Business Operations
Sun & Skin Care Research, LLC		849772207	manufacture