FACE FACTOR- avobenzone, homosalate, octinoxate, octisalate, titanium dioxide lotion 
Kiss My Face, 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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Face Factor

Active ingredients

Avobenzone (3.0%), Homosalate (6.0%), Octinoxate (7.5%), Octisalate (5.0%), Titanium Dioxide (3.0%).

Inactive ingredients

Acetyl Hexapeptide-8, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, a-Lipoic Acid, Aqua, Ascorbyl Palmitate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cucumis Sativus (Cucumber) Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Glycrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Potassium Hydroxide, Saccharide Isomerate, Sodium Hyaluronate, Sorbitan Olivate, Stearyl Alcohol, Styrene/Acrylate Copolymer, Zemea Propanediol.

Keep out of reach of children

Keep out of reach of children.

Directions

Apply liberally 15 minutes before sun exposure

Reapply ater 40 minutes swimming/sweating, immediately after towel drying, and at least every 2 hours

Children under 6 months ask a doctor

Use

Helps prevent sunburn

Purpose

sunscreen

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

If swallowed get medical help or contact a poison control center right away

Package display

image

FACE FACTOR 
avobenzone, homosalate, octinoxate, octisalate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
GLYCERIN (UNII: PDC6A3C0OX)  
LICORICE (UNII: 61ZBX54883)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65364-219-01100 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2015
Labeler - Kiss My Face, LLC (041794279)
Registrant - Kiss My Face, LLC (041794279)

Revised: 1/2015
Document Id: 00e28aae-368c-45ac-97aa-002f3308f1e1
Set id: 7d7f7750-c038-4607-920d-1869cf7d837e
Version: 2
Effective Time: 20150123
 
Kiss My Face, LLC