REVLON PHOTOREADY INSTA-FIX MAKEUP- titanium dioxide, zinc oxide stick 
Revlon Consumer Products Corp

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.

----------

REVLON PHOTOREADY INSTA-FIX MAKEUP

Active Ingredients:

Titanium Dioxide 4.3%

Zinc Oxide 2.8

Purpose:

Sunscreen

Uses:

Warnings:

Directions:

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:

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:

REVLON PHOTOREADY INSTA-FIX MAKEUP

Label

REVLON PHOTOREADY INSTA-FIX MAKEUP 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-631
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.1 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10967-631-2410.35 mL in 1 TUBE; Type 0: Not a Combination Product09/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/14/2014
Labeler - Revlon Consumer Products Corp (788820165)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(10967-631)

Revised: 11/2019
Document Id: 9716f197-0d06-507d-e053-2a95a90a686d
Set id: 442f2a06-47c0-2522-e054-00144ff88e88
Version: 2
Effective Time: 20191111
 
Revlon Consumer Products Corp