SUN ULTIMATE FACE SPF 30- octinoxate, octisalate, homosalate, 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14324-013-00	1 in 1 BOX	01/31/2018
1		50 mL in 1 BOTTLE; 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	01/31/2018

Labeler - NAOS (263520841)