Label: SUN SUBLIME PROTECTIVE FACE CARE SPF 30- homosalate, octisalate, avobenzone cream
- NDC Code(s): 14324-027-00
- Packager: Naos USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (w/w)
- Use
- Warnings
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Directions
Adults 18 years 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
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Inactive ingredients
Aqua/water/eau, Ethylhexyl Methoxycrylene, Glycerin, Glyceryl Stearate, Coco-caprylate/caprate, Propanediol, Silica, Dimethicone, Caprylyl
Methicone, Peg-100 Stearate, Butyloctyl Salicylate, Cera alba/beeswax/cire d´abeille, Tocopheryl Acetate, Cetyl Alcohol, Benzotriazolyl Dodecyl P-cresol, Oryzanol, Pentylene Glycol, Vp/eicosene Copolymer, Fragrance (Parfum), Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Oryza Sativa (Rice) Bran Oil, Pongamol, Soybean Glycerides, Polysilicone-11, Butylene Glycol, Acetyl Tyrosine, Aspartic Acid, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Polyacrylate Crosspolymer-6, Sodium Citrate, Sodium Dextran Sulfate, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Xanthan Gum, Creatine, Dipropylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Hydrolyzed Wheat Protein, Luffa Cylindrica Seed Oil, Oleic Acid, Propylene Glycol, Aminoethanesulfinic Acid, Phenoxyethanol, Carbomer, Sodium Lactate, Caprylyl Glycol, Polysorbate 20, Copper Gluconate, Asiaticoside, Madecassic Acid, Carnosine, Tocopherol, Asiatic Acid, Disodium Adenosine Triphosphate, Artemia Extract, Medicago Sativa (Alfalfa) Extract, Laminaria Digitata Extract, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Acetyl Hexapeptide-1, Dextran, Linalool, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Benzyl Benzoate, Geraniol, Citronellol, Isoeugenol, Coumarin, Citral. - Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
SUN SUBLIME PROTECTIVE FACE CARE SPF 30
homosalate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14324-027 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) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) PROPANEDIOL (UNII: 5965N8W85T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) METHICONE (20 CST) (UNII: 6777U11MKT) PEG-100 STEARATE (UNII: YD01N1999R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) YELLOW WAX (UNII: 2ZA36H0S2V) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETYL ALCOHOL (UNII: 936JST6JCN) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) ORYZANOL (UNII: SST9XCL51M) PENTYLENE GLYCOL (UNII: 50C1307PZG) ENOXOLONE (UNII: P540XA09DR) MANNITOL (UNII: 3OWL53L36A) METHYLPROPANEDIOL (UNII: N8F53B3R4R) RICE BRAN OIL (UNII: LZO6K1506A) PONGAMOL (UNII: 8Y19QCY6I4) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ACETYL L-TYROSINE (UNII: DA8G610ZO5) ASPARTIC ACID (UNII: 30KYC7MIAI) SUNFLOWER OIL (UNII: 3W1JG795YI) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) SODIUM CITRATE (UNII: 1Q73Q2JULR) OLEOYL TYROSINE (UNII: 131P1BQX1U) XANTHAN GUM (UNII: TTV12P4NEE) CREATINE (UNII: MU72812GK0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SODIUM HYDROXIDE (UNII: 55X04QC32I) LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859) OLEIC ACID (UNII: 2UMI9U37CP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYPOTAURINE (UNII: 5L08GE4332) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SODIUM LACTATE (UNII: TU7HW0W0QT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 20 (UNII: 7T1F30V5YH) COPPER GLUCONATE (UNII: RV823G6G67) ASIATICOSIDE (UNII: PKO39VY215) MADECASSIC ACID (UNII: M7O1N24J82) CARNOSINE (UNII: 8HO6PVN24W) TOCOPHEROL (UNII: R0ZB2556P8) ASIATIC ACID (UNII: 9PA5A687X5) ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) LAMINARIA DIGITATA (UNII: 15E7C67EE8) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL BENZOATE (UNII: N863NB338G) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) ISOEUGENOL (UNII: 5M0MWY797U) COUMARIN (UNII: A4VZ22K1WT) CITRAL (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14324-027-00 1 in 1 CARTON 04/01/2022 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 04/01/2022 09/30/2024 Labeler - Naos USA, Inc. (080727572)
