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

SUN ULTIMATE FACE SPF 30 by

Drug Labeling and Warnings

SUN ULTIMATE FACE SPF 30 by is a Otc medication manufactured, distributed, or labeled by Naos USA, Inc., MF PRODUCTIONS SAUMUR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Apply liberally and evenly 15 minutes 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.; and 
• Wear long-sleeve shirts, pants hats and sunglasses.
• Children under 6 months of age: ask a doctor.

Other information

• Keep the product between 15-30°C (59-86°F)
• Protect the product in this container from excessive heat and direct sun.

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:

INGREDIENTS AND APPEARANCE

SUN ULTIMATE FACE SPF 30 
homosalate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14324-020-50	1 in 1 BOX	04/01/2019
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2019

Labeler - NAOS (263520841)

Establishment
Name	Address	ID/FEI	Business Operations
MF PRODUCTIONS SAUMUR		266769145	manufacture(14324-020)