LOREAL PARIS DAY CREAM AGE PERFECT FOR MATURE SKIN ANTI-SAGGING EVEN SKIN TONE HYDRATING SPF 15- ensulizole and octinoxate cream

Loreal Paris Day Cream Age Perfect For Mature Skin Anti-sagging Even Skin Tone Hydrating SPF 15 by

Drug Labeling and Warnings

Loreal Paris Day Cream Age Perfect For Mature Skin Anti-sagging Even Skin Tone Hydrating SPF 15 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ensulizole 1.7%

Octinoxate 7.5%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

Skin Cancer/Skin Agingin 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 a 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 under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

water, cyclohexasiloxane, glycerin, mineral oil, myristyl myristatem stearic acid, ammonium polyacryloyldimethyl taurate, palmitic acid, triethanolamine, titanium dioxide, PEG-100 stearate, glyceryl stearate, acrylates copolymer, alpha-isomethyl ionone, alumina, benzyl alcohol, benzyl benzoate, butylparaben, capryloyl salicylic acid, cetyl alcohol, citronellol, coumarin, cyclodextrin, diazolidinyl urea, disodium EDTA, disodium succinate, fragrance, geraniol, hydrolyzed soy protein, jasminum officinale (jasmin) flower extract, limonene, linalool, mannitol, methylparaben, PEG-20 stearate, phenoxyethanol, propylene glycol, rosa canina fruit oil, sodium hydroxide, soluble collagen, stearyl alcohol, yeast extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS DAY CREAM AGE PERFECT FOR MATURE SKIN ANTI-SAGGING EVEN SKIN TONE HYDRATING SPF 15 
ensulizole and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-548
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	17 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
TROLAMINE (UNII: 9O3K93S3TK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CETYL ALCOHOL (UNII: 936JST6JCN)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COUMARIN (UNII: A4VZ22K1WT)
BETADEX (UNII: JV039JZZ3A)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
GERANIOL (UNII: L837108USY)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MANNITOL (UNII: 3OWL53L36A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-20 STEARATE (UNII: NBX892EA57)
phenoxyethanol (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-548-01	1 in 1 CARTON	01/02/2017
1		96 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49967-548-02	1 in 1 CARTON	01/02/2017
2		70 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-548) , pack(49967-548)