Label: REVLON PHOTOREADY INSTA-FIX MAKEUP- titanium dioxide, zinc oxide stick
- NDC Code(s): 10967-631-24
- Packager: Revlon Consumer Products Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 11, 2019
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- Official Label (Printer Friendly)
- Active Ingredients:
- 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:
Boron Nitride, Phenyl Trimethicone, Ozokerite, Bis-(C12-14 Alkyl PPG-2) Hexamethylenediurea, Sodium Ascorbyl Phosphate, Niacinamide, Hydrolyzed Oat Flour, Tocopheryl Acetate, Lecithin, Phytosteryl Canola Glycerides, Palmitic Acid, Oleic Acid, Ceramide 3, Tocopherol, Phytosphingosine, Hydrogenated Jojoba Oil, Ceramide 6 II, Cholesterol, Ceramide 1, Alumina, Nylon-12, Triethoxycaprylylsilane, Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Sodium Lauroyl Lactylate, Linoleic Acid, Methoxy Amodimethicone/Silsesquioxane Copolymer, Stearic Acid, Triolein, Xanthan Gum, Carbomer, Sorbic Acid
May Contain Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)
- Principal Display Panel:
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INGREDIENTS AND APPEARANCE
REVLON PHOTOREADY INSTA-FIX MAKEUP
titanium dioxide, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-631 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.1 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) ISOHEXADECANE (UNII: 918X1OUF1E) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) BORON NITRIDE (UNII: 2U4T60A6YD) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) NIACINAMIDE (UNII: 25X51I8RD4) OATMEAL (UNII: 8PI54V663Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PALMITIC ACID (UNII: 2V16EO95H1) OLEIC ACID (UNII: 2UMI9U37CP) TOCOPHEROL (UNII: R0ZB2556P8) CERAMIDE 3 (UNII: 4370DF050B) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO) CERAMIDE 6 II (UNII: F1X8L2B00J) CHOLESTEROL (UNII: 97C5T2UQ7J) CERAMIDE 1 (UNII: 5THT33P7X7) ALUMINUM OXIDE (UNII: LMI26O6933) NYLON-12 (UNII: 446U8J075B) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHICONE (20 CST) (UNII: 6777U11MKT) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) LINOLEIC ACID (UNII: 9KJL21T0QJ) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL TRIOLEATE (UNII: O05EC62663) XANTHAN GUM (UNII: TTV12P4NEE) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-631-24 10.35 mL in 1 TUBE; Type 0: Not a Combination Product 09/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/14/2014 Labeler - Revlon Consumer Products Corp (788820165) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(10967-631)
