REVLON PHOTOREADY BB CREAM SKIN PERFECTOR- octinoxate, octisalate, titanium dioxide make-up liquid

Revlon PhotoReady BB Cream Skin Perfector by

Drug Labeling and Warnings

Revlon PhotoReady BB Cream Skin Perfector by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Octinoxate 7.5%

Octosalate 5.0%

Titanium Dioxide 6.5%

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:

Aqua ((Water) Eau), Dimethicone, Neopentyl Glycol Diheptanoate, Butylene Glycol, Glycerin, Pentaerythrityl Tetraisostearate, Phenyl Trimethicone, Glyceryl Stearate, Tridecyl Trimellitrate, Isotridecyl Isonononanoate, Isostearic Acid, Boron Nitride, Alumina, Zinc Gluconate, Sodium Hyaluronate, Hydrogenated Algin, Hydrolyzed Glycosaminoglycine, Hibiscus Sabdariffa Flower Extract, Morus Alba Bark Extract, Glucyrrhiza Glabra (Licorice) Root Extract, Cucumis Sativis (Cucumber) Seed Extrract, Stearic Acid, Polyacrylamide, Steareth-2, Tromethamine, C13-14 Isoparaffin, Steareth-21, Methicone, Xanthan Gum, Laureth-7, Simethicone, Sorbitan Laurate, Polysorbate 20, Propylene Glycol Laurate, Propylene Glycol Stearate, Glyceryl Polymethacrylate, Phenoxyethanol, Methylparaben, Ethylparaben  May Contain: Mica, Titanium Dioxide (CI 77981), Iron Oxides (CI 77491, 77492, 77499)

Principal Display Panel:

​REVLON

PHOTOREADY BB CREAM

SKIN PERFECTOR

BROAD SPECTRUM

SPF 30

1.0 fL. OZ/30 mL

INGREDIENTS AND APPEARANCE

REVLON PHOTOREADY BB CREAM SKIN PERFECTOR 
octinoxate, octisalate, titanium dioxide make-up liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-623
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	6.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
MORUS ALBA BARK (UNII: 7O71A48NDP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
STEARETH-2 (UNII: V56DFE46J5)
TROMETHAMINE (UNII: 023C2WHX2V)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-623-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2014

Labeler - Revlon Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon Consumer Products Corp		809725570	manufacture(10967-623)