PHOTO REGUL FACE SPF 25- octisalate, octinoxate, homosalate, avobenzone cream

PHOTO REGUL FACE SPF 25 by

Drug Labeling and Warnings

PHOTO REGUL FACE SPF 25 by is a Otc medication manufactured, distributed, or labeled by Naos USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octisalate 5.0%

Octinoxate 4.9%

Homosalate 4.0%

Avobenzone 3.0%

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

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 to 1 877 443 3762

Package Labeling:

INGREDIENTS AND APPEARANCE

PHOTO REGUL FACE SPF 25 
octisalate, octinoxate, homosalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	49 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14324-014-00	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)