OP PROTECTIVE MIST 15 OIL FREE- octinoxate, octisalate spray

OP Protective Mist 15 Oil Free by

Drug Labeling and Warnings

OP Protective Mist 15 Oil Free 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

Octinoxate 7.0%
Octisalate 5.0%

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 away from face to avoid breathing in.  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.  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 at temperatures above 120° F.

Directions

• spray evenly and liberally to 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 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OP PROTECTIVE MIST 15 OIL FREE 
octinoxate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62802-915
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62802-915-06	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