MDP UV BIO SUNSCREEN- zinc oxide, homosalate, octocrylene, octisalate cream

MDP UV BIO SUNSCREEN by

Drug Labeling and Warnings

MDP UV BIO SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by SKINIDEA CO., LTD, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

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

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.

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

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

Other information

• Protect the product in this container from excessive heat and direct sun

Questions or comments?

Please send an email to the following address
skinidea@medipeel.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MDP UV BIO SUNSCREEN 
zinc oxide, homosalate, octocrylene, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72220-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	103.8 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	60 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
LAUROYL LYSINE (UNII: 113171Q70B)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROMETHAMINE (UNII: 023C2WHX2V)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
WATERMELON (UNII: 231473QB6R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SALIX ALBA BARK (UNII: 205MXS71H7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU)
APPLE (UNII: B423VGH5S9)
CRANBERRY (UNII: 0MVO31Q3QS)
CERAMIDE NP (UNII: 4370DF050B)
POMEGRANATE (UNII: 56687D1Z4D)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CERAMIDE NG (UNII: C04977SRJ5)
CERAMIDE NS (UNII: V7M2259XJM)
CERAMIDE AP (UNII: F1X8L2B00J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72220-003-02	1 in 1 CARTON	03/01/2025
1	NDC: 72220-003-01	40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2025

Labeler - SKINIDEA CO., LTD (690416325)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(72220-003)