SUN ULTIMATE FACE SPF 30- homosalate, octisalate, avobenzone cream 
Naos USA, Inc.

----------

SUN ULTIMATE FACE CREAM SPF 30

Drug Facts

Active ingredients

Homosalate 9%

Octisalate 4.5%

Avobenzone 2.7

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Do not use 

on broken skin.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if 

rash occurs.

Keep out of reach of children.

If swallowed, call a poison control centre or get medical help right away.

Directions

Adult 18 years old and older:

Other information

Inactive ingredients

Water, Ethylhexyl Methoxycrylene, Butyloctyl Salicylate, Glycerin, Tribehenin Peg-20 Esters, Pentylene Glycol, Coco-Caprylate/Caprate, Dimethicone, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-Cresol, Cetearyl Alcohol Vp/Eicosene Copolymer, C20-22 Alkyl Phosphate, Creatine, Glyceryl Stearate, Glycyrrhetinic Acid, Mannitol, Peg-100 Stearate, C20-22 Alcohols Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Polysilicone-11, Caprylyl Glycol, 1,2-Hexanediol, Sodium Citrate, Hydrolyzed Soy Protein, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Hydrolyzed Wheat Protein, Propylene Glycol, Sodium Hydroxide, Butylene Glycol, Polysorbate 60, Sorbitan Isostearate, Alcohol, Phenoxyethanol, Tris(Tetramethylhydroxypiperidinol) Citrate, Carnosin, Artemia Extract, Disodium Adenosine Triphosphate, Laminaria Digitata Extract, Tocopherol

Questions?

Call 1-877-443-3762

Package Labeling:

Outer Package2Inner Package2

SUN ULTIMATE FACE SPF 30 
homosalate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
CREATINE (UNII: MU72812GK0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ENOXOLONE (UNII: P540XA09DR)  
MANNITOL (UNII: 3OWL53L36A)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARNOSINE (UNII: 8HO6PVN24W)  
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-020-501 in 1 BOX04/01/201909/30/2024
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/201909/30/2024
Labeler - Naos USA, Inc. (080727572)
Establishment
NameAddressID/FEIBusiness Operations
MF PRODUCTIONS SAUMUR266769145manufacture(14324-020)

Revised: 11/2023
Document Id: 0b41a486-6e3a-a1a7-e063-6294a90ace21
Set id: 10345ec6-b490-495c-9b56-c94383e8a212
Version: 3
Effective Time: 20231128
 
Naos USA, Inc.