Versed - Spf 30 Mineral Body Lotion (16-mk-055)

Versed - Spf 30 Mineral Body Lotion (16-mk-055)
SPL v2
SPL
SPL Set ID fb80d364-71a4-8b31-e053-6394a90a3795
Route
TOPICAL
Published
Effective Date 2023-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17.6 g)
Inactive Ingredients
Tetradecane Arachidyl Glucoside Potassium Cetyl Phosphate Green Tea Leaf Sodium Benzoate Hyaluronate Sodium Grape Seed Oil Potassium Sorbate Sodium Stearoyl Glutamate Citric Acid Monohydrate Caprylhydroxamic Acid Docosanol Cetyl Alcohol Propanediol Glycerin Xanthan Gum Diheptyl Succinate Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Medium-chain Triglycerides Caprylyl Glycol Levomenol Sodium Gluconate Water Arachidyl Alcohol Tocopherol Aloe Vera Leaf Butyloctyl Salicylate Theobroma Grandiflorum Seed Butter Methyl Dihydroabietate Sodium Pyrrolidone Carboxylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-01

Description

Zinc Oxide - 17.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide - 17.6%

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 50565-1

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

Section 51727-6

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Vitis Vinifera (Grape) Seed Oil, Methyl Dihydroabietate, Propanediol, Potassium Cetyl Phosphate, Diheptyl Succinate, Arachidyl Alcohol, Cetyl Alcohol, Tetradecane, Sodium Stearoyl Glutamate, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Behenyl Alcohol, Sodium PCA, Theobroma Grandiflorum Seed Butter, Arachidyl Glucoside, Xanthan Gum, Sodium Gluconate, Bisabolol, Citric Acid, Caprylhydroxamic Acid, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Glycerin, Camellia Sinensis Leaf Extract, Tocopherol, Sodium Benzoate, Potassium Sorbate.

Section 51945-4

Section 55105-1

Sunscreen

Warnings
  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
Directions
  • Shake well, apply liberally and evenly 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
  • Children under 6 months of age: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and othe sun protection measures including: limit time in sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses
Active Ingredient

Zinc Oxide - 17.6%

Other Information

Protect this product in this container from excessive heat and direct sun.


Structured Label Content

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Vitis Vinifera (Grape) Seed Oil, Methyl Dihydroabietate, Propanediol, Potassium Cetyl Phosphate, Diheptyl Succinate, Arachidyl Alcohol, Cetyl Alcohol, Tetradecane, Sodium Stearoyl Glutamate, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Behenyl Alcohol, Sodium PCA, Theobroma Grandiflorum Seed Butter, Arachidyl Glucoside, Xanthan Gum, Sodium Gluconate, Bisabolol, Citric Acid, Caprylhydroxamic Acid, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Glycerin, Camellia Sinensis Leaf Extract, Tocopherol, Sodium Benzoate, Potassium Sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Purpose

Sunscreen

Warnings
  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
Directions
  • Shake well, apply liberally and evenly 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
  • Children under 6 months of age: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and othe sun protection measures including: limit time in sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses
Active Ingredient

Zinc Oxide - 17.6%

Other Information (Other information)

Protect this product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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