MAMONDE UV Fluid

Drug Labeling and Warnings

Drug Details [pdf]

MAMONDE UV FLUID- homosalate, octocrylene, octisalate, and avobenzone lotion 
AMOREPACIFIC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MAMONDE UV Fluid

Drug Facts

ACTIVE INGRIDIENTS W/W	Purpose
AVOBENZONE 2.5%	Sunscreen
HOMOSALATE 9%	Sunscreen
OCTISALATE 4.5%	Sunscreen
OCTOCRYLENE 9%	Sunscreen

USE

• 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.

When using this product

• keep out of eyes.
• rinse with water to remove.

Do not use on

• damaged or broken skin.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children

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

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• 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 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.
  • Children under 6 months of age: Ask a doctor.

Other information

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

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, DIMETHICONE, PROPANEDIOL, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, ALCOHOL, VP/EICOSENE COPOLYMER, PEG-10 DIMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, FRAGRANCE / PARFUM, GLYCERYL CAPRYLATE, CALENDULA OFFICINALIS FLOWER EXTRACT, DISODIUM EDTA.

PRINCIPAL DISPLAY PANEL - 35 ml Container Label

Mamonde

UV
FLUID

calendula

Broad Spectrum

SPF 50+

Sunscreen 35 ml / 1.1 fl. oz

MAMONDE UV FLUID 
homosalate, octocrylene, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-806
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.15 g  in 35 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.15 g  in 35 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.575 g  in 35 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.875 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALCOHOL (UNII: 3K9958V90M)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-806-32	35 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/23/2017	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/23/2017	09/01/2019

Labeler - AMOREPACIFIC (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC		694894112	manufacture(43419-806)

Revised: 9/2019

Document Id: 91d22d6c-c041-e0b3-e053-2995a90af1c6

34390-5

Set id: 13befd39-5d6b-4e2f-a41e-10c757739304

Version: 4

Effective Time: 20190905

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