DERMA BRILLIANCE SUNSCREEN SPF 30- octinoxate, oxybenzone, octisalate, avobenzone and octocrylene cream 
Allure Labs, Inc

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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DRUG FACTS

Active Ingredients:

Octinaxate - 7.5%

Oxybenzone - 6.0%

Octisalate - 5.0%

Avobenzone - 2.0%

Octocrylene - 1.5%

Purpose: Sunscreen

Uses:

Warnings:

Discontinue use if irritation or redness occurs.

Consult a doctor if sever irritation occurs.

Directions:

Water, Alkyl(C12-15) Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Hyaluronate Sodium, Kiwi Fruit, Medium chain Triglycerides, Green Tea Leaf, Teprenone, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Cyclomethicone 5, Cyclomethicone 6, Algae Extract, Artemisia Vulgaris Root, Centella Asiatica, Echinacea Purpurea, Lauryl Methacrylate / Glycol Dimethacrylate, Crosspolymer, Carbomer, Yeast Polysaccharides, Triethanolamine,Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene Glycol 400, Tocopherol, Ascorbyl  Palmitate, Ascorbic Acid, Citric Acid Monohydrate, Sorbitan Mono Oleate, Polysorbate 20, Palmitoyl Pentapeptide-4, Darutoside, Glycerin, Polygonum Aviculare Top, Arctostaphylos UVA-URSI Leaf, Mitracarpus Scaber Extract, Plankton Extract, Egg Phospholipids, Micrococcus Lysate, Arabidopsis Thaliana, Ubidecarenone, Edetate Disodium, Aloe Vera Leaf.

Distributed by:

ICTV, 150 Stewart Parkway,

Greensboro, GA 30642 USA 77 Humberline Drive, Toronto,

Ont, Canada M9W0B6.

Image of the Product: Derma Brilliance Sunscreen SPF 30

DERMA BRILLIANCE SUNSCREEN SPF 30 
octinoxate, oxybenzone, octisalate, avobenzone and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
KIWI FRUIT (UNII: 71ES77LGJC)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TEPRENONE (UNII: S8S8451A4O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
UBIDECARENONE (UNII: EJ27X76M46)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Trolamine (UNII: 9O3K93S3TK)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4073-128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/17/2015
Labeler - Allure Labs, Inc (926831603)

Revised: 3/2015
Document Id: 2cf57334-fa04-41f3-964d-edbe1dc8f31e
Set id: 1a3bb5c7-5fe8-4c25-9896-aec185539488
Version: 1
Effective Time: 20150317
 
Allure Labs, Inc