MELAO HYDRATING LIGHTWEIGHT SUNSCREEN- octocrylene,homosalate,ethylhexyl salicylate,phenylbenzimidazole sulfonic acid,butyl methoxydibenzoylmethane,titanium dioxide cream

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

OCTOCRYLENE 9.0%
HOMOSALATE 5.0%
ETHYLHEXYL SALICYLATE 5.0%
PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%
BUTYL METHOXYDIBENZOYLMETHANE 3.0%
TITANIUM DIOXIDE 3.0%

Purpose

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

Stop use and ask a doctor if

rash occurs

Do not use

on damaged or broken skin

When using this product

keep out of the eyes. Rinse with water to remove.

Keep out of reach of children.

If 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.

Inactive ingredients

WATER, BUTYLENE GLYCOL, DIMETHICONE, DICAPRYLYL CARBONATE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, PEG-100 STEARATE, SODIUM HYDROXIDE, GLYCERYL STEARATE, PHENOXYETHANOL, SILICA, HYDROXYACETOPHENONE, ALLANTOIN, PARFUM, DISODIUM EDTA, CERAMIDE NP, PANTHENOL, BISABOLOL, ETHYLHEXYLGLYCERIN, SODIUM HYALURONATE, CENTELLA ASIATICA EXTRACT, TOCOPHEROL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MELAO HYDRATING LIGHTWEIGHT SUNSCREEN 
octocrylene,homosalate,ethylhexyl salicylate,phenylbenzimidazole sulfonic acid,butyl methoxydibenzoylmethane,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	5 g  in 100 mL
PHENYLBENZIMIDAZOLE SULFONIC ACID (UNII: 9YQ9DI1W42) (PHENYLBENZIMIDAZOLE SULFONIC ACID - UNII:9YQ9DI1W42)	PHENYLBENZIMIDAZOLE SULFONIC ACID	3.5 g  in 100 mL
BUTYL METHOXYDIBENZOYLMETHANE (UNII: G63QQF2NOX) (BUTYL METHOXYDIBENZOYLMETHANE - UNII:G63QQF2NOX)	BUTYL METHOXYDIBENZOYLMETHANE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BISABOLOL (UNII: 24WE03BX2T)
ALLANTOIN (UNII: 344S277G0Z)
CERAMIDE NP (UNII: 4370DF050B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICA (UNII: ETJ7Z6XBU4)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-610-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/14/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/14/2026

Labeler - Guangdong Aimu Biological Technology Co., Ltd (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Aimu Biological Technology Co., Ltd		712647107	manufacture(83566-610)