Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

GIORGIO ARMANI CREMA NERA OMC3 OBSIDIAN MINERAL RESTORING SPF 15- avobenzone, octislate and octocrylene cream 
Sicos Et Cie (Lancome)

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 2%, OCTISALATE 5%, OCTOCRYLENE 8%

Use

sunscreen

Directions

Apply before sun exposure

Warnings

For external use only. 

When using this product

avoid the eye contour area. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Discontinue use 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

water, glycerin, alcohol, cetearyl alcohol, petrolatum, shea butter, cetyl alcohol, mannitol, dimethicone, pheoxyethanol

GIORGIO ARMANI CREMA NERA OMC3 OBSIDIAN MINERAL RESTORING SPF 15 
avobenzone, octislate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51150-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EUGENOL (UNII: 3T8H1794QW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51150-066-01	1 in 1 CARTON	09/01/2009	12/31/2013
1		50 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	09/01/2009	12/31/2013

Labeler - Sicos Et Cie (Lancome) (276993581)

Establishment
Name	Address	ID/FEI	Business Operations
Sicos Et Cie (Lancome)		276993581	manufacture(51150-066)

Revised: 8/2019

Document Id: b0585c1c-6b57-4ea7-ac28-fb997cf6668a

34390-5

Set id: 54039481-38c7-43ac-901f-2ddfc7fa1ba8

Version: 4

Effective Time: 20190827