MELAO HYDRATING MINERAL SUNSCREEN- titanium dioxide,zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Titanium dioxide 9%

Zinc oxide 7%

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

For sunscreen use:

·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, GLYCERIN, C12-15 ALKYLBENZOATE, DIMETHICONE,ISODODECANE, STYRENE/ACRYLATESCOPOLYMER, GLYCERYL STEARATE,BUTCTYLY SALICYLATE, DICAPRYLYLCARBONATE, PROPANEDIOL, STEARICACID, ALUMINUM HYDROXIDE,PEG-100 STEARATE, SORBITANSTEARATE, NIACINAMIDE. PEG-8 LAURATE, CERAMIDE NP, CERAMIDEAP, CERAMIDE EOP, SORBITANISOSTEARATE, CARBOMER, CETEARYLALCOHOL, CETEARETH-20,TRIETHOXYCAPRYLYLSILANE,DIMETNICONOL,SODIUM CITRATE,SODIUM LAURAYL LACTYLATE,SODIUM DODECYLBENZENESULFONATE, MYRISTIC ACID, SODIUMHYALURONATE, CHOLESTEROL,PALMITIC ACID, PHENOXYETHANOL,CHLORPHENESIN, TOCOPHEROL,HYDROXYETHYL ACRYLATE/SODIUMACRYLOYLDIMETHYL TAURATECOPOLYMER, CAPRYLYL GLYCOL,CITRIC ACID, PANTHENOL,XANTHANGUM, PHYTOSPHINGOSINE,POLYHYDROXYSTEARIC ACID,POLYSORBATE 60, ETHYLHEXYLGLYCERIN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MELAO HYDRATING MINERAL SUNSCREEN 
titanium dioxide,zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
MYRISTIC ACID (UNII: 0I3V7S25AW)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
CHLORPHENESIN (UNII: I670DAL4SZ)
CARBOMER (UNII: 0A5MM307FC)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
BUTYL SALICYLATE (UNII: QPR9LM8VZO)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CERAMIDE 9 (UNII: 88KCS7120E)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
NIACINAMIDE (UNII: 25X51I8RD4)
CERAMIDE AP (UNII: F1X8L2B00J)
ISODODECANE (UNII: A8289P68Y2)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPANEDIOL (UNII: 5965N8W85T)
CETEARETH-20 (UNII: YRC528SWUY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
XANTHAN GUM (UNII: TTV12P4NEE)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SORBITAN STEARATE (UNII: NVZ4I0H58X)
PEG-8 LAURATE (UNII: 762O8IWA10)
CERAMIDE NP (UNII: 4370DF050B)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
PANTHENOL (UNII: WV9CM0O67Z)
CITRIC ACID (UNII: 2968PHW8QP)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-608-01	75 mL in 1 TUBE; Type 0: Not a Combination Product	04/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/15/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Aimu Biological Technology Co., Ltd		712647107	manufacture(83566-608)