NDC Code(s) : 54181-004-15
Packager : Guinot SAS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GUINOT Large Defense uv Medium protection Sunscreen for the body SPF 20AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54181-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE29 mg in 1 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE120 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE27 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIBUTYL ADIPATE(UNII: F4K100DXP3)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
DIETHYLHEXYL 2,6-NAPHTHALATE(UNII: I0DQJ7YGXM)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
SQUALANE(UNII: GW89575KF9)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SODIUM STEAROYL GLUTAMATE(UNII: 65A9F4P024)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
GLYCERIN(UNII: PDC6A3C0OX)
POLYSORBATE 60(UNII: CAL22UVI4M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BETAINE(UNII: 3SCV180C9W)
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW)(UNII: Q04O53779D)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
PECTIN(UNII: 89NA02M4RX)
SUCROSE(UNII: C151H8M554)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
OLEOYL TYROSINE(UNII: 131P1BQX1U)
CAPRYLOYL GLYCINE(UNII: 8TY5YO42NJ)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
OLEIC ACID(UNII: 2UMI9U37CP)
COPPER GLUCONATE(UNII: RV823G6G67)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54181-004-151 in 1 PACKAGE
1150 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/02/2014

PRINCIPAL DISPLAY PANEL

Guinot Institut Paris

Large Defense UV

Medium Protection Sunscreen Lotion for the Body

30 FPS UVA/UVB SPF

Medium Protection

Broad Spectrum

e150ml NET WT 5.2 OZ

PRINCIPAL DISPLAY PANEL

Large Defense UV