Label: LYCOGEL BREATHABLE BALM- octinoxate,oxybenzone,octisalate and avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51790-400-01 - Packager: Quura Medical B.V
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 1, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Actives
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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
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INGREDIENTS AND APPEARANCE
LYCOGEL BREATHABLE BALM
octinoxate,oxybenzone,octisalate and avobenzone creamProduct 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)
