CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 JAVA- octinoxate, titanium dioxide cream

CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 JAVA by

Drug Labeling and Warnings

CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 JAVA by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC, KOLMAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OCTINOXATE 4.0%

TITANIUM DIOXIDE 3.0%

Purpose

Sunscreen

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

• For external use only

• 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:

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor.

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

• Protect this product from excessive heat and direct sun

Questions or comments?

• Call toll free 1-800 326-7337

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 JAVA 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.28 g  in 32 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	.96 g  in 32 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2070-1	1 in 1 BOX
1	NDC: 67938-2070-2	32 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 67938-2070-3	25000 g in 1 PAIL; 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	06/24/2015

Labeler - ELIZABETH ARDEN, INC (849222187)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR		001535103	MANUFACTURE(67938-2070)