CREMA NERA EXTREMA SPF 14- avobenzone, homosalate, octisalate, octocrylene cream

Crema Nera Extrema SPF 14 by

Drug Labeling and Warnings

Crema Nera Extrema SPF 14 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

CREMA NERA EXTREMA SPF 14 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-010
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	70 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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TOCOPHEROL (UNII: R0ZB2556P8)
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)
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 ANHYDROUS (UNII: 8NLQ36F6MM)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-010-00	1 in 1 BOX	12/25/2017
1		30 mL in 1 BOTTLE; 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	12/25/2017

Labeler - BPS 60 (272259304)