LYCOGEL BREATHABLE BALM- octinoxate,oxybenzone,octisalate and avobenzone cream

Lycogel Breathable Balm by

Drug Labeling and Warnings

Lycogel Breathable Balm by is a Otc medication manufactured, distributed, or labeled by Quura Medical B.V, Allure Cosmetic Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 

Tube label 2

INGREDIENTS AND APPEARANCE

LYCOGEL BREATHABLE BALM 
octinoxate,oxybenzone,octisalate and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51790-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51790-400-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	12/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/07/2017

Labeler - Quura Medical B.V (489419151)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Cosmetic Inc.		926831603	manufacture(51790-400)