REVLON AGE DEFYING WITH DNA ADVANTAGE SPF 20- octinoxate, titanium dioxide make-up liquid

Revlon Age Defying with DNA Advantage SPF 20 by

Drug Labeling and Warnings

Revlon Age Defying with DNA Advantage SPF 20 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:

Octinoxate: 3.5%

Titanium Dioxide 9.5%

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,BUTYLENE GLYCOL,GLYCERIN,NEOPENTYL GLYCOL DIHEPTANOATE,ISOSTEARIC ACID,PHENYL TRIMETHICONE,ISOCETYL STEARATE,PENTAERYTHRITYL TETRAISOSTEARATE,ISOTRIDECYL ISONONANOATE,NYLON-12,TRIETHANOLAMINE,POLYACRYLAMIDE,GLYCERYL STEARATE,CAPRYLYL GLYCOL,1,2-HEXANEDIOL,ALUMINA,STEARETH-2,PHOSPHOLIPIDS,C13-14 ISOPARAFFIN,STEARETH-21,METHICONE,LAURETH-7,XANTHAN GUM,MALPIGHIA GLABRA (ACEROLA) FRUIT EXTRACT,NIACINAMIDE,SIMETHICONE,SACCHAROMYCES/PODOPHYLLUM PELTATUM FERMENT FILTRATE,GOSSYPIUM HERBACEUM (COTTON) EXTRACT,VIOLA TRICOLOR EXTRACT,TOCOPHERYL ACETATE,SODIUM LAUROYL LACTYLATE,SODIUM HYALURONATE,HYDROLYZED GLYCOSAMINOGLYCANS,CERAMIDE 3,CERAMIDE 6 II,PHYTOSPHINGOSINE,CARBOMER,ACETYL HEXAPEPTIDE-8,CHOLESTEROL,CERAMIDE 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVLON AGE DEFYING WITH DNA ADVANTAGE SPF 20 
octinoxate, titanium dioxide make-up liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
METHICONE (20 CST) (UNII: 6777U11MKT)
LAURETH-7 (UNII: Z95S6G8201)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
TROLAMINE (UNII: 9O3K93S3TK)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
STEARETH-2 (UNII: V56DFE46J5)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
STEARETH-21 (UNII: 53J3F32P58)
XANTHAN GUM (UNII: TTV12P4NEE)
MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M)
NIACINAMIDE (UNII: 25X51I8RD4)
LEVANT COTTON SEED (UNII: 550E4N439V)
VIOLA TRICOLOR (UNII: 9Q24RAI43V)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 1 (UNII: 5THT33P7X7)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-616-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/01/2010

Labeler - Revlon Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(10967-616)