REVLON PHOTOREADY INSTA-FIX MAKEUP- titanium dioxide, zinc oxide stick

REVLON PHOTOREADY INSTA-FIX MAKEUP by

Drug Labeling and Warnings

REVLON PHOTOREADY INSTA-FIX MAKEUP by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp, REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 4.3%

Zinc Oxide 2.8

Purpose:

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 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.

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

INGREDIENTS AND APPEARANCE

REVLON PHOTOREADY INSTA-FIX MAKEUP 
titanium dioxide, zinc oxide stick

Product 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)