LOreal Paris Dermo Expertise SPF 15 Active Daily Moisture by L'Oreal USA Products Inc Drug Facts

LOreal Paris Dermo Expertise SPF 15 Active Daily Moisture by

Drug Labeling and Warnings

LOreal Paris Dermo Expertise SPF 15 Active Daily Moisture 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 DERMO EXPERTISE SPF 15 ACTIVE DAILY MOISTURE- 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 2%; Octinoxate 7%

Warnings

FOR EXTERNAL USE ONLY. 

When using this product

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

Stop use and ask a doctor if

SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR.

Keep out of reach of children.

NOT TO BE SWALLOWED. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

HOW/WHEN TO USE

Smooth gently onto face and neck until thoroughly absorbed. Use alone or under makeup daily prior to sun exposure.

Inactive ingredients

water, glycerin, cyclopentasiloxane, polyglyceryl-3 methylglucose distearate, triethanolamine, butyrospermum parkii (shea butter), prunus armeniaca (apricot) kernel oil, pentylene glycol, stearic acid, carbomer, panthenol, cetyl alcohol, xanthan gum, PEG-100 stearate, glyceryl stearate, stearyl alcohol, myristyl alcohol, disodium EDTA, phenoxyethanol, methylparaben, chlorphenesin, butylparaben, yellow 5, fragrance, limonene, benzyl salicylate, linalool, burtylphenyl methylpropional, hexyl cinnamal, benzyl benzoate, citronellol, eugenol, citral.

LOREAL PARIS DERMO EXPERTISE SPF 15 ACTIVE DAILY MOISTURE 
ensulizole and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	20 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
STEARIC ACID (UNII: 4ELV7Z65AP)
PANTHENOL (UNII: WV9CM0O67Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL BENZOATE (UNII: N863NB338G)
EUGENOL (UNII: 3T8H1794QW)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-159-01	1 in 1 CARTON	07/01/2011	07/11/2014
1		118 mL in 1 BOTTLE, PLASTIC; 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	07/01/2011	07/11/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		624244349	manufacture(49967-159)

Revised: 1/2020

Document Id: 8d7dfdb7-fd64-4b76-9f94-574deb5ee71e

34390-5

Set id: b7b42818-22d1-4404-af71-924917b992a8

Version: 4

Effective Time: 20200117

 

L'Oreal USA Products Inc