PHOTO REGUL CREAM UNIFYING PROTECTIVE FACE CARE SPF 25- homosalate, octisalate, avobenzone cream 
Naos USA, Inc.

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Drug Facts

Active ingredients (w/w)

Homosalate 9%
Octisalate 4.5%
Avobenzone 2.7%

Purpose

Sunscreen

Use

Helps 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 of reach of children.

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

Directions

Adults 18 years and older:

Other information

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?

Call 1-877-443-3762

Package Labeling:

Outer Package2Inner Package2

PHOTO REGUL CREAM UNIFYING PROTECTIVE FACE CARE SPF 25 
homosalate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-026-001 in 1 CARTON04/01/202209/30/2024
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/202209/30/2024
Labeler - Naos USA, Inc. (080727572)

Revised: 11/2023
Document Id: 0b41d8d2-7efe-4f4e-e063-6394a90a09e7
Set id: cf3b97e7-2ccf-451d-a92a-011f4a6ed0b0
Version: 2
Effective Time: 20231128
 
Naos USA, Inc.