Label: PHOTO REGUL CREAM UNIFYING PROTECTIVE FACE CARE SPF 25- homosalate, octisalate, avobenzone cream
- NDC Code(s): 14324-026-00
- 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, Propanediol, Silica, Tribehenin Peg-20 Esters, Dimethicone, Dibutyl Adipate, Dipropylene
Glycol, Butyloctyl Salicylate, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-cresol, Pentylene Glycol, Fragrance (Parfum), C20-22 Alkyl Phosphate, Creatine, Glyceryl Stearate, Mannitol, Methylpropanediol, Peg-100 Stearate, Soybean Glycerides, C20-22 Alcohols, Glycyrrhetinic Acid, Polysilicone-11, Vp/eicosene Copolymer, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Acetyl Tyrosine, Aspartic Acid, Helianthus Annuus (Sunflower) Seed Oil, Xanthan Gum, Sodium Citrate, Sodium Dextran Sulfate, Palmaria Palmata Extract, Maltodextrin, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Hydrolyzed Wheat Protein, Luffa Cylindrica Seed Oil, Andrographis Paniculata Leaf Extract, Oleic Acid, Propylene Glycol, Butylene Glycol, Aminoethanesulfinic Acid, Phenoxyethanol, Caprylyl Glycol, Copper Gluconate, Carnosine, Disodium Adenosine Triphosphate, Artemia Extract, Medicago Sativa (Alfalfa) Extract, Tocopherol, Laminaria Digitata Extract, Linalool, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Benzyl Benzoate, Geraniol, Citronellol, Isoeugenol, Coumarin, Citral. - Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PHOTO REGUL CREAM UNIFYING PROTECTIVE FACE CARE SPF 25
homosalate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14324-026 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) PROPANEDIOL (UNII: 5965N8W85T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) DIMETHICONE (UNII: 92RU3N3Y1O) DIBUTYL ADIPATE (UNII: F4K100DXP3) DIPROPYLENE GLYCOL (UNII: E107L85C40) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) PENTYLENE GLYCOL (UNII: 50C1307PZG) C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) CREATINE (UNII: MU72812GK0) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MANNITOL (UNII: 3OWL53L36A) METHYLPROPANEDIOL (UNII: N8F53B3R4R) PEG-100 STEARATE (UNII: YD01N1999R) C20-22 ALCOHOLS (UNII: O4M0347C6A) ENOXOLONE (UNII: P540XA09DR) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM HYDROXIDE (UNII: 55X04QC32I) ACETYL L-TYROSINE (UNII: DA8G610ZO5) ASPARTIC ACID (UNII: 30KYC7MIAI) SUNFLOWER OIL (UNII: 3W1JG795YI) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) PALMARIA PALMATA (UNII: 7832HOY4ZQ) MALTODEXTRIN (UNII: 7CVR7L4A2D) OLEOYL TYROSINE (UNII: 131P1BQX1U) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859) ANDROGRAPHIS PANICULATA TOP (UNII: I49U6EUL9X) OLEIC ACID (UNII: 2UMI9U37CP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYPOTAURINE (UNII: 5L08GE4332) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COPPER GLUCONATE (UNII: RV823G6G67) CARNOSINE (UNII: 8HO6PVN24W) MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) TOCOPHEROL (UNII: R0ZB2556P8) LAMINARIA DIGITATA (UNII: 15E7C67EE8) 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:14324-026-00 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)
