LYCOGEL BREATHABLE BALM- octinoxate,oxybenzone,octisalate and avobenzone cream 
Quura Medical B.V

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.

----------

Actives

OCTINOXATE,OXYBENZONE,OCTISALATE and AVOBENZONE

Inactives

Water (Aqua)

C12-15 Alkyl Benzoate

Octinoxate

Oxybenzone

Octisalate

Butylene Glycol

Octyldodecyl Neopentanoate

Caprylic/Capric Triglyceride

Avobenzone

Octocrylene

Glycerin

Sodium Hyaluronate

Camellia Sinensis Leaf Extract

Teprenone

Cyclopentasiloxane

Cyclohexasiloxane

Actinidia Chinensis (Kiwi) Fruit Extract

Algae Extract

Artemisia Vulgaris Extract

Saccharomyces Lysate Extract

Centella Asiatica Extract

Echinacea Purpurea Extract

Yeast Polysaccharides

Carbomer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

PEG-8

Triethanolamine

Phenoxyethanol

Caprylyl Glycol

Ethylhexylglycerin

Hexylene Glycol

Tocopherol

Ascorbyl Palmitate

Citric Acid

Zinc PCA

Mannitol

Lonicera Japonica (Honeysuckle) Flower Extract

Sodium Citrate

Xanthium Sibiricum Fruit Extract

Aloe Barbadensis Leaf Extract

Cyperus Rotundus Root Extract

Acetyl Tetrapeptide-15

Sodium Benzoate

Sorbitan Oleate

Polysorbate 20

Palmitoyl Pentapeptide-4

Arctostaphylos Uva Ursi Leaf Extract

Plankton Extract

Mitracarpus Scaber Extract

Olea Europaea (Olive) Leaf  Extract

Darutoside

Xanthan Gum

Micrococcus Lysate

Arabidopsis Thaliana Extract

Ubiquinone

Hydroxydecyl Ubiquinone

Disodium EDTA

Phospholipids

Retinyl Palmitate

Beta-Carotene

Ascorbic Acid

Malus Domestica Fruit Cell Culture Extract

Lecithin

Tube Label 

product label

Tube label 2

Tube

LYCOGEL BREATHABLE BALM 
octinoxate,oxybenzone,octisalate and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51790-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TEPRENONE (UNII: S8S8451A4O)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
KIWI FRUIT (UNII: 71ES77LGJC)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
MANNITOL (UNII: 3OWL53L36A)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959)  
ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
DARUTOSIDE (UNII: EG8ODI0780)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
UBIDECARENONE (UNII: EJ27X76M46)  
IDEBENONE (UNII: HB6PN45W4J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
APPLE (UNII: B423VGH5S9)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51790-400-0160 mL in 1 TUBE; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/07/2017
Labeler - Quura Medical B.V (489419151)
Establishment
NameAddressID/FEIBusiness Operations
Allure Cosmetic Inc.926831603manufacture(51790-400)

Revised: 1/2018
Document Id: c289d903-04fe-4055-a9ef-45835981e031
Set id: 46e854cb-6694-4e57-b6e4-15684dfab80b
Version: 1
Effective Time: 20180101
 
Quura Medical B.V