Mdp Uv Bio Sunscreen

Mdp Uv Bio Sunscreen
SPL v1
SPL
SPL Set ID 3087771e-2ab8-2198-e063-6294a90a37d4
Route
TOPICAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (103.8 mg) Homosalate (60 mg) Octocrylene (50 mg) Octisalate (45 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Propanediol Glycerin Cocoyl Caprylocaprate Cetearyl Olivate 1,2-hexanediol Pentylene Glycol Sorbitan Olivate Cetostearyl Alcohol Glyceryl Monostearate Potassium Cetyl Phosphate Lauroyl Lysine Hydroxyacetophenone Panthenol Sodium Polyacryloyldimethyl Taurate Triethoxycaprylylsilane Stearic Acid Tromethamine Neopentyl Glycol Diethylhexanoate Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Trisodium Ethylenediamine Disuccinate Watermelon Citric Acid Monohydrate N-acetylglucosamine Hyaluronate Sodium Biosaccharide Gum-1 Ethylhexylglycerin Gluconolactone Salix Alba Bark Butylene Glycol Caprylyl Glycol Fragaria Vesca Fruit Apple Cranberry Ceramide Np Pomegranate Cholesterol Phytosphingosine Ceramide Ng Ceramide Ns Ceramide Ap Sodium Acetylated Hyaluronate Hyaluronic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Zinc Oxide 10.38%, Homosalate 6% Octocrylene 5%, Ethylhexyl salicylate 4.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 10.38%, Homosalate 6% Octocrylene 5%, Ethylhexyl salicylate 4.5%

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 51945-4

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

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

Directions

For sunscreen use:

■ Apply liberally 15 minutes before sun exposure

■ Use a water-resistant sunscreen if swimming or sweating

■ Reapply at least every 2 hours

■ Sun Protection Measures: Spending time in the sun in creases your risk of

Sun Protection Measures.

Spending time in the sun in creases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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-sleeve shirts, pants, hats, and sunglasses ● Children under 6 months: Ask a doctor

Do Not Use
  • on damaged or broken skin
Drug Facts

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

Zinc Oxide 10.38%, Homosalate 6%

Octocrylene 5%, Ethylhexyl salicylate 4.5%

Inactive Ingredients:

Water, Caprylic/Capric Triglyceride, Propanediol, Glycerin, Coco-Caprylate/Caprate, Cetearyl Olivate, 1,2-Hexanediol, Pentylene Glycol, Sorbitan Olivate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Lauroyl Lysine, Polyhydroxystearic Acid, Hydroxyacetophenone, Panthenol, Sodium Polyacryloyldimethyl Taurate, Triethoxycaprylylsilane, Acrylates Copolymer, Stearic Acid, Tromethamine, Sphingomonas Ferment Extract, Neopentyl Glycol Diethylhexanoate, Polyacrylate Crosspolymer-6, Hydroxypropyl Methylcellulose Stearoxy Ether, Trisodium Ethylenediamine Disuccinate, Citrullus Lanatus (Watermelon) Fruit Extract, Citric Acid, Acetyl Glucosamine, Sodium Hyaluronate, Biosaccharide Gum-1, Ethylhexylglycerin, Sodium Hyaluronate Crosspolymer, Gluconolactone, Salix Alba (Willow) Bark Extract, Butylene Glycol, Hydrogenated Lecithin, Caprylyl Glycol, Fragaria Vesca (Strawberry) Fruit Extract, Malus Domestica Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Ceramide NP, Punica Granatum Fruit Extract, Cholesterol, Hydroxypropyltrimonium Hyaluronate, Phytosphingosine, Ceramide NG, Ceramide NS, Ceramide AP, Ceramide AS, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Potassium Hyaluronate, Ceramide EOP, Fragrance

Questions Or Comments?

Please send an email to the following address

[email protected]

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs
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
  • 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 51945-4 (51945-4)

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

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

Directions

For sunscreen use:

■ Apply liberally 15 minutes before sun exposure

■ Use a water-resistant sunscreen if swimming or sweating

■ Reapply at least every 2 hours

■ Sun Protection Measures: Spending time in the sun in creases your risk of

Sun Protection Measures.

Spending time in the sun in creases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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-sleeve shirts, pants, hats, and sunglasses ● Children under 6 months: Ask a doctor

Do Not Use (Do not use)
  • on damaged or broken skin
Drug Facts

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

Zinc Oxide 10.38%, Homosalate 6%

Octocrylene 5%, Ethylhexyl salicylate 4.5%

Inactive Ingredients: (Inactive ingredients:)

Water, Caprylic/Capric Triglyceride, Propanediol, Glycerin, Coco-Caprylate/Caprate, Cetearyl Olivate, 1,2-Hexanediol, Pentylene Glycol, Sorbitan Olivate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Lauroyl Lysine, Polyhydroxystearic Acid, Hydroxyacetophenone, Panthenol, Sodium Polyacryloyldimethyl Taurate, Triethoxycaprylylsilane, Acrylates Copolymer, Stearic Acid, Tromethamine, Sphingomonas Ferment Extract, Neopentyl Glycol Diethylhexanoate, Polyacrylate Crosspolymer-6, Hydroxypropyl Methylcellulose Stearoxy Ether, Trisodium Ethylenediamine Disuccinate, Citrullus Lanatus (Watermelon) Fruit Extract, Citric Acid, Acetyl Glucosamine, Sodium Hyaluronate, Biosaccharide Gum-1, Ethylhexylglycerin, Sodium Hyaluronate Crosspolymer, Gluconolactone, Salix Alba (Willow) Bark Extract, Butylene Glycol, Hydrogenated Lecithin, Caprylyl Glycol, Fragaria Vesca (Strawberry) Fruit Extract, Malus Domestica Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Ceramide NP, Punica Granatum Fruit Extract, Cholesterol, Hydroxypropyltrimonium Hyaluronate, Phytosphingosine, Ceramide NG, Ceramide NS, Ceramide AP, Ceramide AS, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Potassium Hyaluronate, Ceramide EOP, Fragrance

Questions Or Comments? (Questions or comments?)

Please send an email to the following address

[email protected]

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 occurs
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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