LOreal Paris Revitalift Clinical Repair 10 SPF 20 by L'Oreal USA Products Inc Drug Facts

LOreal Paris Revitalift Clinical Repair 10 SPF 20 by

Drug Labeling and Warnings

LOreal Paris Revitalift Clinical Repair 10 SPF 20 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 REVITALIFT CLINICAL REPAIR 10 SPF 20- avobenzone, homosalate, octisalate and octocrylene 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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocryene 7%

Directions

Every morning, smooth gently over the entire face until thoroughly absorbed. Apply prior to sun exposure. Use alone or under makeup daily.

Warnings

FOR EXTERNAL USE ONLY.

When using this product

AVOID CONTACT WITH 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.

Inactive ingredients

glycerin, cetyl alcohol, glyceryl stearate, PEG-40 stearate, sorbitan tristearate, glycine soja (soybean) oil, sodium hydroxide, retinol, ammonium polyacryloyldimethyltaurate, hydrolyzed soy protein, caprylyl glycol, acetyl trifluoromethylphenyl valyglycine, phenoxyethanol, chlorhexidine digluconate, linalool, geraniol, alphaisomethyl ionone, coumarin, limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, citronellol, butylphenyl methylpropional, benzyl alcohol, benzyl salicylate, fragrance

LOREAL PARIS REVITALIFT CLINICAL REPAIR 10 SPF 20 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-689
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
RETINOL (UNII: G2SH0XKK91)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GERANIOL (UNII: L837108USY)
COUMARIN (UNII: A4VZ22K1WT)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-689-01	1 in 1 CARTON	08/01/2011	03/21/2016
1		50 mL in 1 TUBE; 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	08/01/2011	03/21/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		624244349	manufacture(49967-689)

Revised: 1/2020

Document Id: a50e201f-895d-450b-a315-dc3fe45acf12

34390-5

Set id: ac9557b4-9425-4492-a48e-712e6c3161cf

Version: 3

Effective Time: 20200117

 

L'Oreal USA Products Inc