PHOTO REGUL FACE SPF 25- octisalate, octinoxate, homosalate, avobenzone cream 
Naos USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PHOTO REGUL FACE SPF 25

Drug Facts

Active Ingredients

Octisalate 5%

Octinoxate 4.9%

Homosalate 4%

Avobenzone 3%

Purpose

Sunscreen

Uses

Help 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 reach of children.

If swallowed, call a poison control centre or get medical help right away.

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

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

Inactive Ingredients

Water, Dicaprylyl Carbonate, Ethylhexyl Methoxycrylene, Glycerin, Propanediol, Tribehenin Peg-20 Esters, Methyl Methacrylate Crosspolymer, Alcohol Denat., Tocopheryl Acetate, Paraffinum Liquidum / Mineral Oil/Huile Minerale, Creatine, Fragrance (Parfum), Glyceryl Stearate, Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Peg-100 Stearate, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trilinolein, Chlorphenesin, Acetyl Tyrosine, Aspartic Acid, Cerium Oxide, Helianthus Annuus (Sunflower) Seed Oil, Xanthan Gum, Disodium Edta, Sodium Dextran Sulfate, Sodium Hydroxide, Palmaria Palmata Extract, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Pentaerthrityl Tetra-Di-T-Butylhydroxyhydrocinnamate, Butylene Glycol, Triolein, Tripalmitin, Hydrolyzed Wheat Protein, Silica, Andrographis Paniculata Leaf Extract, Oleic Acid, Medicago Sativa (Alfalfa) Extract, Trilinolenin, Propylene Glycol, Alcohol, Tris(Tetramethylhydroxypiperidinol) Citrate, Tristearin, Caprylyl Glycol, Copper Gluconate, Bht, Artemia Extract, Carnosine, Tocopherol, Triarachidin, Disodium Adenosine Triphosphate, Laminaria Digitata Extract, Potassium Sorbate, Red 33 (Ci 17200)

Question?

Call 1 877 443 3762

Package Labeling:

Outer Label4Inner Label4Label4

PHOTO REGUL FACE SPF 25 
octisalate, octinoxate, homosalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE49 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MINERAL OIL (UNII: T5L8T28FGP)  
CREATINE (UNII: MU72812GK0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ENOXOLONE (UNII: P540XA09DR)  
MANNITOL (UNII: 3OWL53L36A)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRILINOLEIN (UNII: V5LJ52OGS7)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
N-ACETYLTYROSINE (UNII: DA8G610ZO5)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
CERIC OXIDE (UNII: 619G5K328Y)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DULSE (UNII: 7832HOY4ZQ)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
OLEOYL TYROSINE (UNII: 131P1BQX1U)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL TRIOLEATE (UNII: O05EC62663)  
TRIPALMITIN (UNII: D133ZRF50U)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANDROGRAPHIS PANICULATA TOP (UNII: I49U6EUL9X)  
OLEIC ACID (UNII: 2UMI9U37CP)  
ALFALFA (UNII: DJO934BRBD)  
TRILINOLENIN (UNII: OI7S0A9873)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)  
TRISTEARIN (UNII: P6OCJ2551R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COPPER GLUCONATE (UNII: RV823G6G67)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARNOSINE (UNII: 8HO6PVN24W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIARACHIDIN (UNII: 48RPR95FW8)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-014-001 in 1 BOX01/31/201808/31/2022
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/31/201808/31/2022
Labeler - Naos USA, Inc. (080727572)

Revised: 10/2022
Document Id: ea2f4e25-6f26-2d85-e053-2a95a90a119f
Set id: 64432435-7051-09ba-e053-2991aa0aca13
Version: 5
Effective Time: 20221004
 
Naos USA, Inc.