Label: CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COCOA- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0950-1, 67938-0950-2, 67938-0950-3 - Packager: ELIZABETH ARDEN, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 16, 2015
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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
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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.
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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
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INGREDIENTS AND APPEARANCE
CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COCOA
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-0950 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:67938-0950-1 1 in 1 BOX 1 NDC:67938-0950-2 32 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:67938-0950-3 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(67938-0950)
