Melan Mineral Antioxidant Body Mist Mineral Sunscreen Spf 30

Melan Mineral Antioxidant Body Mist Mineral Sunscreen Spf 30
SPL v1
SPL
SPL Set ID 210823a0-94f9-4833-b279-fc26b9061195
Route
TOPICAL
Published
Effective Date 2024-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (120 mg)
Inactive Ingredients
Adansonia Digitata Seed Oil Allantoin Aloe Vera Leaf Arachidyl Alcohol Arachidyl Glucoside Behenyl Alcohol Butyloctyl Salicylate Caprylic/capric Triglyceride Carthamus Tinctorius (safflower) Seed Oil Citric Acid Monohydrate Citrullus Lanatus (watermelon) Fruit Extract Citrus Aurantium Dulcis (orange) Peel Oil Citrus Paradisi (grapefruit) Seed Oil Cocos Nucifera (coconut) Oil Decyl Glucoside Dodecane Ethylhexylglycerin Eucalyptus Globulus Leaf Oil Glycerin Glyceryl Stearate Se Mentha Piperita (peppermint) Oil Basil Panthenol Phenoxyethanol Polysorbate 20 Potassium Cetyl Phosphate Propanediol Rosmarinus Officinalis (rosemary) Extract Tocopherol Xanthan Gum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-08

Description

Zinc Oxide 12.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 12.00%

Uses
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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
Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Do Not Use
  • on damaged or broken skin.
Drug Facts

Questions?

1-888-676-3890

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients

Zinc Oxide 12.00%

Package Labelling:
Inactive Ingredients

Adansonia Digitata Oil, Allantoin, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Seed Oil, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate SE, Mentha Piperita (Peppermint) Oil, Ocimum Basilicum (Basil) Extract, Panthenol, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Tocopherol, Xanthan Gum, Water (Aqua)

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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
Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Questions?

1-888-676-3890

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients

Zinc Oxide 12.00%

Package Labelling:
Inactive Ingredients

Adansonia Digitata Oil, Allantoin, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Seed Oil, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate SE, Mentha Piperita (Peppermint) Oil, Ocimum Basilicum (Basil) Extract, Panthenol, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Tocopherol, Xanthan Gum, Water (Aqua)

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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