DERMA PELLA SUNSCREEN ADVANCE CREAM-GEL- octocrylene, avobenzone, ethylhexyl salicylate, phenylbenzimidazole sulfonic acid, polysilicone-15, titanium dioxide cream 
Pella Pharmaceuticals Co. Ltd

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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Sunscreen Advance

Form and Presentation

Cream-Gel: Plastic Tube, 50 g

Active Ingredients

Octocrylene, Butyl Methoxydibenzoylmethane (Avobenzone), Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Polysilicone-15, Titanium Dioxide

Inactive Ingredients

Aqua, Butylene Glycol Dicaprylate/Dicaprate, Potassium Cetyl Phosphate, Silica, Diisopropyl Sebacate, Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Behenyl Alcohol, Tromethamine, VP/Hexadecene Copolymer, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Ethylhexylglycerin

Purpose

Sunscreen

Properties

This product is developed to be suitable for all types of skin, with high sun protection factors (SPF 50 +) and optimum combination of UVB/UVA filters, they efficiently protect the skin pigmentation spots and skin ageing.

It is fast absorbing with dry touch and matte feel for optimal protection without leaving any white residue on skin.

Paraben Free, Water resistant.

Indications

Sunscreen for all skin types

Precautions

Keep out of reach of children

Warnings

- If irritation occurs, immediately rinse with water and discontinue use.
- If irritation persists, consult with a physician.
- Keep away from your eyes, in case of eye contact, flush with water.
- For external use only.

Contraindications

Hypersensitivity to any of the components.

Side Effects

There are no known side effects.

Dosage and Administration

Apply a sufficient amount of the sunscreen about 15 minutes before sun exposure on intact skin and massage gently. Reapply every 2 hours, after swimming, or sport.

Storage Conditions

Store below 30 C.

Primary Package

Primary Package

Secondary Package

Secondary Package

DERMA PELLA SUNSCREEN ADVANCE CREAM-GEL 
octocrylene, avobenzone, ethylhexyl salicylate, phenylbenzimidazole sulfonic acid, polysilicone-15, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-726
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE20 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE16 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29) POLYSILICONE-1520 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
DOCOSANOL (UNII: 9G1OE216XY)  
HEXADECYL POVIDONE (UNII: AG75W62QYU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82160-726-011 in 1 CARTON12/26/2022
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02012/26/2022
Labeler - Pella Pharmaceuticals Co. Ltd (562370925)

Revised: 6/2023
Document Id: fe95fdbf-73e0-a587-e053-6394a90a53a0
Set id: fe95fdbf-73df-a587-e053-6394a90a53a0
Version: 1
Effective Time: 20230620
 
Pella Pharmaceuticals Co. Ltd