SUN ULTIMATE FACE SPF 30- octinoxate, octisalate, homosalate, avobenzone cream 
NAOS

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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SUN ULTIMATE CREAM FACE SPF 30

Drug Facts

Active Ingredients

Octinoxate 7.0%

Octisalate 5.0%

Homosalate 4.0%

Avobenzone 2.5%

Purpose

Sunscreen

Purpose

Sunscreen

Uses

Help 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 reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply liberally, and spread evenly by hand 15 min 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-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Other information

  • Keep the product between 15-30ºC.
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aqua/Water, Dicaprylyl Carbonate, Glycerin, Pongamia Glabra Seed Oil, Potassium Cetyl Phosphate, Vp/Eicosene Copolymer, Ethylhexyl Methoxycrylene, Glyceryl Stearate, Peg-100 Stearate, Cetyl Alcohol, Tocopheryl Acetate, C20-22 Alkyl Phosphate, Creatine, Glycyrrhetinic Acid, Mannitol, C20-22 Alcohols, Sodium Dextran Sulfate, Phenoxyethanol, Chlorphenesin, Acrylates/C10-30 Alkylacrylate Crosspolymer, Cerium Oxide, Disodium Edta, Hydrolyzed Soy Protein, Sodium Hydroxide, Hydrolyzed Wheat Protein, Propylene Glycol, Butylene Glycol, Alcohol, Caprylyl Glycol, Artemia Extract, Tris(Tetramethylhydroxypiperidinol) Citrate, Carnosine, Bht, Xanthan Gum, Algae Extract, Disodium Adenosine Triphosphate, Tocopherol, Potassium Sorbate.

Question?

Call to 1-877-443-3762

Package Labeling:

Outer Package2Inner Package2

SUN ULTIMATE FACE SPF 30 
octinoxate, octisalate, homosalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)  
CARNOSINE (UNII: 8HO6PVN24W)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
CREATINE (UNII: MU72812GK0)  
ENOXOLONE (UNII: P540XA09DR)  
MANNITOL (UNII: 3OWL53L36A)  
C20-22 ALCOHOLS (UNII: O4M0347C6A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERIC OXIDE (UNII: 619G5K328Y)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-013-001 in 1 BOX01/31/201810/31/2020
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/31/201810/31/2020
Labeler - NAOS (263520841)

Revised: 5/2020
 
NAOS