GIORGIO ARMANI CREMA NERA EXTREMA ESSENTIAL DEFENSE FLUID BROAD SPECTRUM SPF 14 SUNSCREEN- 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.

----------

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging 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 in this container from excessive heat and direct sun

Inactive ingredients

water, gllycerin, bifida ferment lysate, silica, alcohol denat., dimethicone, isopropyl lauroyl sarcosinate, styrene/acrylates copolymer, PEG-100 stearate, glyceryl stearate, tocopherol, synthetic wax, tamarindus indica seed polysaccharide, camellia oleifera seed oil, myrothamnus flabellifolia leaf extract, PEG-8 laurate, dicaprylyl carbonate, stearic acid, stearyl alcohol, potassium chloride, nigella sativa seed oil, triethanolamine, dimethicone/vinyl dimethicone crosspolymer, trehalose, methylsilanol mannuronate, sodium lactate, myristic acid, myristyl alcohol, rhamnose, palmitic acid, adenosine, magnesium sulfate, ascorbyl glucoside, ammonium polyacryloyldimethyl taurate, disodium EDTA, disodium phosphate, capparis spinosa fruit extract, capryloyl salicylic acid, caprylyl glycol, citric acid, xanthan gum, scutellaria baicalensis root extract, t-butyl alcohol, cetyl alcohol, octyldodecyl myristate, sorbic acid, sodium benzoate, phenoxyethanol, linalool, geraniol, alpha-isomethyl ionone, citronellol, hexyl cinnamal, benzyl alcohol, benzyl salicylate, fragrance

image of a carton

GIORGIO ARMANI CREMA NERA EXTREMA ESSENTIAL DEFENSE FLUID BROAD SPECTRUM SPF 14 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-432
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
MYROTHAMNUS FLABELLIFOLIA LEAF (UNII: 6Y9E0R40J5)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
TREHALOSE (UNII: B8WCK70T7I)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
RHAMNOSE (UNII: QN34XC755A)  
PALMITIC ACID (UNII: 2V16EO95H1)  
ADENOSINE (UNII: K72T3FS567)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
CAPER BERRY (UNII: 7G4C45EE8C)  
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
SORBIC ACID (UNII: X045WJ989B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
GERANIOL (UNII: L837108USY)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-432-011 in 1 CARTON03/31/201707/27/2020
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-432-021 mL in 1 PACKET; Type 0: Not a Combination Product03/31/201707/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/31/201707/27/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Sicos et Cie276993581manufacture(49967-432)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-432)
Establishment
NameAddressID/FEIBusiness Operations
Socoplan276221405pack(49967-432)

Revised: 1/2023
 
L'Oreal USA Products Inc