MIMI LUZON - FACE DEFENCE BROAD SPECTRUM SPF 30 SUNSCREEN SERUM- titanium dioxide and zinc oxide liquid 
Cosmetic Solutions LLC

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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Mimi Luzon - Face Defence Broad Spectrum SPF 30 Sunscreen Serum

DRUG FACTS:

ACTIVE INGREDIENTS

Titanium Dioxide 7.2%, Zinc Oxide 4.0%.}

PURPOSE

Sunscreen

USES

Helps prevent sunburn.

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.

DIRECTIONS

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor. 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:

INACTIVE INGREDIENTS

Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Propanediol, Polyglyceryl-10 Oleate, Coco-Caprylate/Caprate, Styrene/Acrylates Copolymer, Polyhydroxystearic Acid, Rosa Damascena Flower Water, Phenoxyethanol, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Alumina, Butylene Glycol, Polyglyceryl-2 Caprate, Microcrystalline Cellulose, Potassium Cetyl Phosphate, Polyglyceryl-3 Polyricinoleate, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Marrubium Vulgare Meristem Cell Culture, Polyglyceryl-3 Diisostearate, Triethoxycaprylylsilane, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Cellulose Gum, Glyceryl Caprylate, Squalane, Carbomer, Polysorbate 20, Aspalathus Linearis Extract, Palmitoyl Tripeptide-1, Xanthan Gum, Palmitoyl Tetrapeptide-7, Polygonum Aviculare Extract.

OTHER INFORMATION

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

Manufactured by: Cosmetic Solutions
6101 Park of Commerce Blvd, Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

MIMILUZON

Protection
Formula

P

Face Defence
Broad Spectrum SPF 30
Sunscreen Serum

50ml ℮ 1.7 fl.oz

Principal Display Panel - 50 ml Bottle Label
MIMI LUZON - FACE DEFENCE BROAD SPECTRUM SPF 30 SUNSCREEN SERUM 
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-2701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide7.2 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethicone (UNII: 92RU3N3Y1O)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Propanediol (UNII: 5965N8W85T)  
Polyglyceryl-10 Oleate (UNII: 55C81W76DH)  
Cocoyl Caprylocaprate (UNII: 8D9H4QU99H)  
Rosa X Damascena Flower Oil (UNII: 18920M3T13)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Aluminum Stearate (UNII: U6XF9NP8HM)  
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
Aluminum Oxide (UNII: LMI26O6933)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Polyglyceryl-2 Caprate (UNII: JX7WXJ41DH)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Polyglyceryl-3 Pentaricinoleate (UNII: 7Q0OK5DOT4)  
Jojoba Oil (UNII: 724GKU717M)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Sucrose Stearate (UNII: 274KW0O50M)  
Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)  
Squalane (UNII: GW89575KF9)  
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Palmitoyl Tripeptide-1 (UNII: RV743D216M)  
Xanthan Gum (UNII: TTV12P4NEE)  
Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)  
Polygonum Aviculare Top (UNII: ZCD6009IUF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-2701-150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2021
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 10/2021
Document Id: 3cefb3c9-ed6e-4544-837a-a7003abe0dc8
Set id: 54125af8-1feb-4652-8c47-b7993c6851d2
Version: 1
Effective Time: 20211001
 
Cosmetic Solutions LLC