LOreal Paris Skin Expertise Collagen Moisture Filler Daily Moisturizer Day SPF 15 by L'Oreal USA Products Inc Drug Facts

LOreal Paris Skin Expertise Collagen Moisture Filler Daily Moisturizer Day SPF 15 by

Drug Labeling and Warnings

LOreal Paris Skin Expertise Collagen Moisture Filler Daily Moisturizer Day SPF 15 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LOREAL PARIS SKIN EXPERTISE COLLAGEN MOISTURE FILLER DAILY MOISTURIZER DAY SPF 15- ensulizole and octinoxate lotion 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

ENSULIZOLE 1.8%; OCTINOXATE 7.5%

Directions

Use daily on the face. Apply before sun exposure.

Warnings

FOR EXTERNAL USE ONLY. 

When using this product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. 

Stop use

IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A DOCTOR.

Keep out of reach of children.

NOT TO BE SWALLOWED.

Inactive ingredients

water, dimethicone

LOREAL PARIS SKIN EXPERTISE COLLAGEN MOISTURE FILLER DAILY MOISTURIZER DAY SPF 15 
ensulizole and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	18 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-130-01	1 in 1 CARTON	06/01/2009	01/15/2017
1		60 mL in 1 BOTTLE, PUMP; 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	06/01/2009	01/15/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		624244349	manufacture(49967-130)

Revised: 1/2020

Document Id: b0f6f883-d7fe-4325-876c-7fc18b65fa41

34390-5

Set id: 5567e562-e6ed-4dc7-8715-8926486e11f8

Version: 3

Effective Time: 20200117

 

L'Oreal USA Products Inc