FDA.reportPublic FDA data

PHOTO REGUL FACE SPF 25

Manufacturer
Naos USA, Inc.
Effective date
2022-01-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:19:03

Label at a glance#

ProductPHOTO REGUL FACE SPF 25
Active ingredientOCTISALATE, OCTINOXATE, HOMOSALATE, AVOBENZONE
Label structure8 sections

Indications and uses

Help prevent sunburn.

Dosage and administration

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 incl...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5%

Octinoxate 4.9%

Homosalate 4%

Avobenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Help prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on broken skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1 877 443 3762

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label4Outer Label4Inner Label4Inner Label4Label4Label4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14324-01414324-014-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
TRIBEHENIN PEG-20 ESTERS84K9EH29Y9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MINERAL OILT5L8T28FGPIACT
CREATINEMU72812GK0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ENOXOLONEP540XA09DRIACT
MANNITOL3OWL53L36AIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRILINOLEINV5LJ52OGS7IACT
CHLORPHENESINI670DAL4SZIACT
N-ACETYLTYROSINEDA8G610ZO5IACT
ASPARTIC ACID30KYC7MIAIIACT
CERIC OXIDE619G5K328YIACT
SUNFLOWER OIL3W1JG795YIIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM HYDROXIDE55X04QC32IIACT
DULSE7832HOY4ZQIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
OLEOYL TYROSINE131P1BQX1UIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL TRIOLEATEO05EC62663IACT
TRIPALMITIND133ZRF50UIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW)J2S07SB0YLIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ANDROGRAPHIS PANICULATA TOPI49U6EUL9XIACT
OLEIC ACID2UMI9U37CPIACT
ALFALFADJO934BRBDIACT
TRILINOLENINOI7S0A9873IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE7NW772I64YIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ea2f4e25-6f26-2d85-e053-2a95a90a119f64432435-7051-09ba-e053-2991aa0aca132022-10-04WarningsExact identifier
spl set id: 64432435-7051-09ba-e053-2991aa0aca13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.