SUNSPRAY- avobenzone, homosalate, octinoxate, octisalate, titanium dioxide spray 
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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Sunspray Lotion

Active ingredients

Avobenzone (3.0%), Homosalate (5.0%), Octinoxate (7.5%), Octisalate (6.5%), Titanium Dioxide (2.0%).

Inactive ingredients

Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Water, Zemea Propanediol.

Keep out of reach of children

Keep out of reach of children.

Directions

Apply liberally 15 minutes before sun exposure

Do not spray directly on face

Reapply ater 80 minutes of swimming or sweating, immediately after towel drying, at least ever 2 hours

Children under 6 months ask a doctor

Use

Helps prevent sunburn

Purpose

sunscreen

Warnings

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

SUNSPRAY 
avobenzone, homosalate, octinoxate, octisalate, titanium dioxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-218
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) HOMOSALATE5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE6.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
DAUCUS CAROTA SUBSP. CAROTA WHOLE (UNII: Q5AR3Y25MQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EUCALYPTUS GUNNII LEAF OIL (UNII: 45P837MS5Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65364-218-01100 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: c9c86d45-0999-4b7d-81c1-9605fec5192d
Set id: 5fae3a70-2e9a-44fa-99aa-c905de534144
Version: 2
Effective Time: 20150127
 
Kiss My Face, LLC