CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COCOA- octinoxate, titanium dioxide cream 
ELIZABETH ARDEN, INC

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.

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Drug Facts

Active ingredients

OCTINOXATE 4.0%

TITANIUM DIOXIDE 3.0%

Purpose

Sunscreen

Sunscreen

Uses

Warnings

  • Do not use on damaged or broken skin

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions For Sunscreen Use:

Inactive Ingredients

WATER/AQUA/EAU, CYCLOPENTASILOXANE, DIMETHICONE, ISOHEXADECANE, MICA, GLYCERIN, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, ALUMINA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, ACETYL OCTAPEPTIDE-3, ALANINE, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, ASPARTIC ACID, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL DEXTRIN, DISODIUM EDTA, FRUCTOSE, GLUCOSE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, LECITHIN, MANNITOL, PCA DIMETHICONE PHYTOSPHINGOSINE, POLYPERFLUOROETHOXYMET HOXY DIFLUOROETHYL PEG PHOSPHATE, POLYQUATERNIUM-51, RETINYL PALMITATE, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SORBITOL, SUCROSE, TOCOPHEROL, TREHALOSE, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT UREA, XANTHAN GUM, ZINC STEARATE, BHT, BENZOIC ACID CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Other Information

Questions or comments?

Principal Display Panel - Carton Label

Elizabeth Arden

NEW YORK

Ceramide

Lift and Firm Makeup

Broad Spectrum Sunscreen SPF 15

NET WT. 1 OZ. 32 g

Principal Display Panel - Carton Label
CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COCOA 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0950
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.28 g  in 32 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE.96 g  in 32 g
Inactive Ingredients
Ingredient NameStrength
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)  
ALANINE (UNII: OF5P57N2ZX)  
ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FRUCTOSE (UNII: 6YSS42VSEV)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
MANNITOL (UNII: 3OWL53L36A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICA (UNII: V8A1AW0880)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TREHALOSE (UNII: B8WCK70T7I)  
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0950-11 in 1 BOX
1NDC:67938-0950-232 g in 1 JAR; Type 0: Not a Combination Product
2NDC:67938-0950-325000 g in 1 PAIL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/24/2015
Labeler - ELIZABETH ARDEN, INC (849222187)
Establishment
NameAddressID/FEIBusiness Operations
KOLMAR001535103MANUFACTURE(67938-0950)

Revised: 7/2015
Document Id: ebb40664-e6cc-474a-b37e-ddf742247fd6
Set id: 6c06ffdc-5f9c-42c3-98d4-c3ddd0c1a3d9
Version: 4
Effective Time: 20150716
 
ELIZABETH ARDEN, INC