Label: SUN ULTIMATE FACE SPF 30- homosalate, octisalate, avobenzone cream
- NDC Code(s): 14324-020-50
- Packager: Naos USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Use
- Warnings
-
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
-
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?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SUN ULTIMATE FACE SPF 30
homosalate, octisalate, avobenzone creamProduct 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 09/30/2024 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 Drug M020 04/01/2019 09/30/2024 Labeler - Naos USA, Inc. (080727572) Establishment Name Address ID/FEI Business Operations MF PRODUCTIONS SAUMUR 266769145 manufacture(14324-020)
