Zinka Clear Zinc Oxide Sunscreen

Zinka Clear Zinc Oxide Sunscreen
SPL v7
SPL
SPL Set ID 7b097f5e-8127-49e6-8a77-4ee1fded5ff1
Route
TOPICAL
Published
Effective Date 2024-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (50 mg) Zinc Oxide (43 mg) Octisalate (30 mg) Oxybenzone (25 mg)
Inactive Ingredients
Water Aloe Vera Leaf Isopropyl Myristate Hydrogenated Polybutene (370 Mw) Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate Ethylhexyl Palmitate Cetyl Dimethicone 150 Magnesium Sulfate Anhydrous White Wax Hydrogenated Castor Oil Edetate Disodium .alpha.-tocopherol Acetate Vitamin A Palmitate Propylene Glycol Caprylyl Glycol Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-03-01

Description

Octinoxate 5.0% w/w Zinc Oxide 4.3% w/w Octisalate 3.0% w/w Oxybenzone 2.5% w/w

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 5.0% w/w Zinc Oxide 4.3% w/w Octisalate 3.0% w/w Oxybenzone 2.5% w/w

Section 50565-1

Keep out of reach of children.  If product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4

​uses
  • Helps prevent sunburn and skin damage caused by UVA/UVB exposure
  • Higher SPF gives more sunburn protection
Purposes

Sunscreen

​warnings

For external use only

​directions
  • Apply liberally 20 minutes before sun exposure to dry skin
  • Reapply to dry skin after toweling, swimming or sweating
  • For children under 6 months of age: Ask a doctor
Active Ingredients

Octinoxate 5.0% w/w

Zinc Oxide 4.3% w/w

Octisalate 3.0% w/w

Oxybenzone 2.5% w/w

​other Information

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

​inactive Ingredients

Water, Isopropyl Myristate, Aloe Barbadensis Leaf Extract, Diisostearoyl Polyglyceryl-3 Diisostearate, Hydrogenated Polyisobutene, Cetyl Dimethicone, Octyl Palmitate, Retinyl Palmitate, Tocopheryl Acetate, Magnesium Sulfate, Propylene Glycol, White Bees Wax, Hydrogenated Castor Oil, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone

​when Using This Product
  • Keep out of eyes.  Rinse with water to remove
  • Do not use if allergic to any ingredient
  • Keep out of reach of children
  • If swallowed, contact Poison Control Center immediately
​stop Use and Ask Doctor If
  • Rash or irritation develops and lasts

Structured Label Content

Section 50565-1 (50565-1)

Keep out of reach of children.  If product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4 (51945-4)

​uses (​Uses)
  • Helps prevent sunburn and skin damage caused by UVA/UVB exposure
  • Higher SPF gives more sunburn protection
Purposes

Sunscreen

​warnings (​Warnings)

For external use only

​directions (​Directions)
  • Apply liberally 20 minutes before sun exposure to dry skin
  • Reapply to dry skin after toweling, swimming or sweating
  • For children under 6 months of age: Ask a doctor
Active Ingredients

Octinoxate 5.0% w/w

Zinc Oxide 4.3% w/w

Octisalate 3.0% w/w

Oxybenzone 2.5% w/w

​other Information (​Other information)

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

​inactive Ingredients (​Inactive Ingredients)

Water, Isopropyl Myristate, Aloe Barbadensis Leaf Extract, Diisostearoyl Polyglyceryl-3 Diisostearate, Hydrogenated Polyisobutene, Cetyl Dimethicone, Octyl Palmitate, Retinyl Palmitate, Tocopheryl Acetate, Magnesium Sulfate, Propylene Glycol, White Bees Wax, Hydrogenated Castor Oil, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone

​when Using This Product (​When using this product)
  • Keep out of eyes.  Rinse with water to remove
  • Do not use if allergic to any ingredient
  • Keep out of reach of children
  • If swallowed, contact Poison Control Center immediately
​stop Use and Ask Doctor If (​Stop use and ask doctor if)
  • Rash or irritation develops and lasts

Advanced Ingredient Data


Raw Label Data

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