Photo Regul Cream Unifying Protective Face Care SPF 25 by Naos USA, Inc.

Drug Details [pdf]

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:

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

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 Package2 Inner Package2

PHOTO REGUL CREAM UNIFYING PROTECTIVE FACE CARE SPF 25
homosalate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-026
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/01/2022	09/30/2024

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