OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone cream

Oscar de la Renta Moisturizing Sunscreen SPF 30 by

Drug Labeling and Warnings

Oscar de la Renta Moisturizing Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Oscar de la Renta LLC, Suite K Value Added Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 5%
Oxybenzone 6%

Use

• helps prevent sunburn
  

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

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

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Directions

For sunscreen use

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children 6 months of age: Ask a doctor
  

Other information

• protect the product in this container from excessive heat and direct sun
  

Inactive ingredients

WATER, ISODECYL NEOPENTANOATE, GLYCERIN, FRAGRANCE, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, COCOGLYCERIDES, PHENOXYETHANOL, CYCLOPENTASILOXANE, SODIUM POLYACRYLATE, CAPRYLYL GLYCOL, HEXYL CINNAMAL, BENZYL SALICYLATE, OAT (AVENA SATIVA) KERNEL EXTRACT, LIMONENE, SORBIC ACID, BHT, HYDROXYCITRONELLOL, CYCLOHEXASILOXANE, LINALOOL, CITRONELLOL, GERANIOL, ETHYLHEXYLLAURATE, COCOYL HYDROLYZED WHEAT PROTEIN, HYDROLYZED SOY PROTEIN

Purpose

Sunscreen

PRINCIPAL DISPLAY PANEL

Oscar de La Renta MOISTURIZING SUNSCREEN CREAM SPF 30    e120 ML 5 FL OZ  
DISTRIBUTED BY:   Oscar de La Renta 6 AVENUE DEL'EUROPE  77600 BUSSY SAINT GEORGES, FRANCE   
II WEST 42ND STREET  NEW YORK, NY 10018   MADE IN USE   oscardelarenta.com

Oscar de la Renta Moisturizing Sunscreen Cream SPF 30 120ml/5 Fl OZ (

45124-001-05)

INGREDIENTS AND APPEARANCE

OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45124-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
OAT (UNII: Z6J799EAJK)
SORBIC ACID (UNII: X045WJ989B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYCITRONELLOL (UNII: R0B4U2I48W)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
ETHYLHEXYL LAURATE (UNII: 8J6M396U72)
SOY PROTEIN (UNII: R44IWB3RN5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45124-001-05	1 in 1 CARTON
1		120 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/11/2012

Labeler - Oscar de la Renta LLC (071007918)

Establishment
Name	Address	ID/FEI	Business Operations
Suite K Value Added Services LLC		036822144	manufacture