FDA Label for Sunscreen Water Resistant

View Indications, Usage & Precautions

Sunscreen Water Resistant Product Label

The following document was submitted to the FDA by the labeler of this product 220 Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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


Otc - 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.

Otc - 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)


Otc - 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


Package Label.Principal Display Panel



Zinka Clear continuous sunscreen sprayMega mist water resistantBroad spectrumUVA/UVB ProtectionNon-greasy, no slip gripFast and even application

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