Label: ALMAY SMART SHADE CC CREAM- octinoxate, octisalate, titanium dioxide make-up liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0311-0705-01 - Packager: Almay
- Category: HUMAN OTC DRUG LABEL
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 December 5, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients:
- Purpose:
- Uses:
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Warnings:
- For external use only
- Do notuse 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 a rash occurs
- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away
Directions:
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor.
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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am - 2 pm
- Wear long-sleeved shirts, pants, hats and sunglasses.
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Inactive Ingredients:
AQUA ((WATER) EAU),DIMETHICONE,NEOPENTYL GLYCOL DIHEPTANOATE,BUTYLENE GLYCOL,GLYCERIN,PENTAERYTHRITYL TETRAISOSTEARATE,PHENYL TRIMETHICONE,GLYCERYL STEARATE,TRIDECYL TRIMELLITATE,ISOTRIDECYL ISONONANOATE,ISOSTEARIC ACID,BORON NITRIDE,ALUMINA,PALMITOYL TRIPEPTIDE-5,ACETYL HEXAPEPTIDE-8,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,VITIS VINIFERA (GRAPE) FRUIT EXTRACT,SAXIFRAGA SARMENTOSA (STRAWBERRY SAXIFRAGE) EXTRACT,SODIUM HYALURONATE,HYDROLYZED GLYCOSAMINOGLYCANS,SCUTELLARIA BAICALENSIS (BAIKAL SKULLCAP) ROOT EXTRACT,MORUS BOMBYCIS(CHINES MULBERRY) ROOT EXTRACT,ASCORBYL GLUCOSIDE,NIACINAMIDE,DIPOTASSIUM GLYCYRRHIZATE,C13-14 ISOPARAFFIN,XANTHAN GUM,SIMETHICONE,LAURETH-7,LECITHIN,SORBITAN LAURATE,POLYSORBATE 20,PROPYLENE GLYCOL LAURATE,PROPYLENE GLYCOL STEARATE,METHICONE,STEARIC ACID,STEARETH-2,TROMETHAMINE,POLYACRYLAMIDE,POLYMETHYL METHACRYLATE,STEARETH-21,PHENOXYETHANOL,METHYLPARABEN,ETHYLPARABEN
May Contain Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)
- Principal Display Panel:
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INGREDIENTS AND APPEARANCE
ALMAY SMART SHADE CC CREAM
octinoxate, octisalate, titanium dioxide make-up liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0311-0705 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) TROMETHAMINE (UNII: 023C2WHX2V) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) ISOSTEARIC ACID (UNII: X33R8U0062) BORON NITRIDE (UNII: 2U4T60A6YD) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) STEARETH-2 (UNII: V56DFE46J5) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) STEARETH-21 (UNII: 53J3F32P58) METHICONE (20 CST) (UNII: 6777U11MKT) XANTHAN GUM (UNII: TTV12P4NEE) LAURETH-7 (UNII: Z95S6G8201) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP) PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) MORUS ALBA ROOT (UNII: CST1G9BZGD) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PEG-10 SORBITAN LAURATE (UNII: 4Z93U4C2WN) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0311-0705-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 04/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/22/2013 Labeler - Almay (064988652) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(0311-0705)
