SUNSCREEN WATER RESISTANT- homosalate oxybenzone octisalate avobenzone octylcrylene aerosol, spray

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by 220 Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                              Purpose

Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

Homosalate 15.0%............................................................Sunscreen

Benzophenone-3 5.0%.......................................................Sunscreen

Octocrylene 2.0%..............................................................Sunscreen

Ethylhexyl Salicylate 5.0%.................................................Sunscreen

WHEN USING

When Using this product

• Keep out of reach of children
  
• Keep out of eyes. Rinse with water to remove.
  
• Do not use if allergic to any ingredient.
  
• If swallowed, get medical help or contact Poison Control Center immediately.

WARNINGS

Warnings

• For external use only
• Do not spray directly into face
• Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  

ASK DOCTOR

Stop use and ask doctor if

• Rash or irritation develops.

STORAGE AND HANDLING

Flammable

• Do not use near heat, open flame or while smoking.
• Do not puncture or incinerate. Contents under pressure.
• Do not store at temperature about 120°F (49°C).
• Avoid long term storage about 104°F (40°C).
  

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly to all areas 15 minutes before sun exposure.
• Spray on hands and apply to face.
• Use in well-ventilated area.
• Reapply to dry skin as needed.
• Ask doctor before use on children under six months of age.
  

GENERAL PRECAUTIONS

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

INACTIVE INGREDIENT

Other Ingredients

Butane, Alcohol Denat., Taploca Starch, Zinc Oxide, Retinyl Palmitate, Zea Mays (Corn) oil, Cholecalciferol, Tocopheryl Acetate, Panthenol, Tetrahexyldecyl Ascorbate, Ascorbyl Palmitate, Acrylates/Octylacylamide Copolymer, Fragrance (Parfum)

PURPOSE

Active Ingredients                                               Purpose

Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

Homosalate 15.0%............................................................Sunscreen

Benzophenone-3 5.0%.......................................................Sunscreen

Octocrylene 2.0%..............................................................Sunscreen

Ethylhexyl Salicylate 5.0%.................................................Sunscreen

PRINCIPAL DISPLAY PANEL

Zinka Clear continuous sunscreen spray
Mega mist water resistant
Broad spectrum
UVA/UVB Protection
Non-greasy, no slip grip
Fast and even application

INGREDIENTS AND APPEARANCE

SUNSCREEN  WATER RESISTANT
homosalate oxybenzone octisalate avobenzone octylcrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57367-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, TAPIOCA (UNII: 24SC3U704I)
ZINC OXIDE (UNII: SOI2LOH54Z)
COUMARIN (UNII: A4VZ22K1WT)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
PANTHENOL (UNII: WV9CM0O67Z)
BENZYL BENZOATE (UNII: N863NB338G)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57367-029-05	106 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/10/2010

Labeler - 220 Laboratories Inc (783247950)

Registrant - 220 Laboratories Inc (783247950)

Establishment
Name	Address	ID/FEI	Business Operations
220 Laboratories Inc		783247950	manufacture