NDC Code(s) : 61957-2218-1
Packager : Parfums Christian Dior

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Hydra Life Water BB SPF 30 Shade 020BENZOPHENONE-3, OCTINOXATE, PHENYLBENZIMIDAZOLE SULFONIC ACID, TITANIUM DIOXIDE EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61957-2218
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE30 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE74.9 mg in 1 mL
ENSULIZOLE(UNII: 9YQ9DI1W42)
(ENSULIZOLE - UNII:9YQ9DI1W42) 		ENSULIZOLE20 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE32 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PROPANEDIOL(UNII: 5965N8W85T)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
ALCOHOL(UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYGLYCERIN-3(UNII: 4A0NCJ6RD6)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
BETAINE(UNII: 3SCV180C9W)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SQUALANE(UNII: GW89575KF9)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL(UNII: KD6TZ2QICH)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CENTELLA ASIATICA LEAF(UNII: 6810070TYD)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
EDETATE SODIUM(UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALUMINUM OXIDE(UNII: LMI26O6933)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYSORBATE 60(UNII: CAL22UVI4M)
POLYGLYCERYL-10 STEARATE(UNII: 90TF85HH91)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
MALVA SYLVESTRIS FLOWERING TOP(UNII: X1U1U0N90J)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
HABERLEA RHODOPENSIS LEAF(UNII: N042Q65701)
SANGUISORBA OFFICINALIS ROOT(UNII: 4NYV2HT01X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
CARAMEL(UNII: T9D99G2B1R)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
TOCOPHEROL(UNII: R0ZB2556P8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61957-2218-11 in 1 BOX 17/01/2016
130 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/17/2016 12/12/2020

PRINCIPAL DISPLAY PANEL

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