SUNSCREEN WATER RESISTANT

Dosage form: aerosol, spray
Ingredients: HOMOSALATE 150mg in 1g, OXYBENZONE 50mg in 1g, OCTISALATE 50mg in 1g, AVOBENZONE 30mg in 1g, OCTOCRYLENE 20mg in 1g
Labeler: 220 Laboratories Inc
NDC Code: 57367-029

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.

SPF-30 Artwork

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 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

  • 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.

Stop use and ask doctor if
  • Rash or irritation develops.

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).

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.

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.

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)

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

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


SUNSCREEN  WATER RESISTANT
homosalate oxybenzone octisalate avobenzone octylcrylene aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-029
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE150 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE50 mg  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 g
AVOBENZONE (AVOBENZONE) AVOBENZONE30 mg  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, TAPIOCA 
ZINC OXIDE 
COUMARIN 
BENZYL SALICYLATE 
PANTHENOL 
BENZYL BENZOATE 
ASCORBYL PALMITATE 
TETRAHEXYLDECYL ASCORBATE 
VITAMIN A PALMITATE 
CORN OIL 
CHOLECALCIFEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
Packaging
#Item CodePackage Description
1NDC:57367-029-05106 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/10/2010
Labeler - 220 Laboratories Inc (783247950)
Registrant - 220 Laboratories Inc (783247950)
Establishment
NameAddressID/FEIOperations
220 Laboratories Inc783247950manufacture

Revised: 05/2010
 
220 Laboratories Inc

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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