EXTREME AHAVA EXTREME DAILY FIRMNESS AND PROTECTION BROAD SPECTRUM SPF30- homosalate, octisalate, avobenzone, ensulizole, and o

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Active ingredient:
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S), Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W), Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX), Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42), Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)
Available from:
AHAVA Dead Sea Laboratories Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
60289-285-24

EXTREME AHAVA EXTREME DAILY FIRMNESS AND PROTECTION BROAD

SPECTRUM SPF30- homosalate, octisalate, avobenzone, ensulizole, and octocrylene lotion

AHAVA Dead Sea Laboratories Ltd

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.

----------

EXTREME

AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30

Drug Facts

Active ingredients

Purpose

Avobenzone [2.99%]

sunscreens

Ensulizole [2%]

sunscreens

Homosalate [7%]

sunscreens

Octisalate [5%]

sunscreens

Octocrylene [0.86%]

sunscreens

Us es

helps prevent sunburn

Warnings

For External Use Only

When using this product keep out of eyes. Rinse with water to remove

Stop use and consult a doctor if rash or irritation develops and lasts

Do not use on damaged or broken skin

Keep out of reach of children. If swallowed, get medical attention or contact a Poison Control Center

right away

Directions

apply liberally and evenly to clean face 15 minutes before sun exposure

apply daily for a clearer, brighter complexion

children under 6 months of age: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin

aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher

and other sun protection measures including:

limit time in the sun, especially from 10a.m.-2 p.m.

wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients

Aqua (Mineral Spring Water), Glycerin, C15-19 Alkane, Caprylyl Methicone, Cetyl Alcohol, Oryza

Sativa (Rice) Bran Oil, Saccharide Isomerate, Cellulose Acetate, Maris Aqua (Dead Sea Water),

Dunaliella Salina (Dead Sea Alga) Extract, Cetraria Islandica (Iceland Moss) Extract, Allantoin, Lycium

Barbarum (Tibetian GojiBerry) Fruit Extract, Tocopherol (Vitamin E), Phoenix Dactylifera (Date) Fruit

Extract, Folic Acid, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Galactoarabinan, Helianthus

Extract, Folic Acid, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Galactoarabinan, Helianthus

Annuus (Sunflower) Seed Oil, Glyceryl Stearate, Phenoxyethanol, Aminomethyl Propanol, Boron

Nitride, Dimethicone, Butylene Glycol, Ceteth-20, Steareth-20, Caprylyl Glycol, PEG-75 Stearate,

Chlorphenesin, Xanthan Gum, Disodium EDTA, Hydrogenated Polydecene, Dimethiconol, Sclerotium

Gum, Lysolecithin, Pullulan, Carbomer, Parfum (Fragrance), Geraniol, Citronellol, Coumarin, Alpha

Isomethyl Ionone, Limonene, Linalool, Citric Acid, Sodium Citrate, Polysorbate 20, Potassium Sorbate,

Sodium Benzoate.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

AHAVA

TIME TO REVITALIZE

EXTREME LOTION

DAILY FIRMNESS &

PROTECTION

BROAD SPECTRUM SPF 30

50 ml e 1.7 fl.oz

EXTREME AHAVA EXTREME DAILY FIRMNESS AND PROTECTION BROAD

SPECTRUM SPF30

homosalate, octisalate, avobenzone, ensulizole, and octocrylene lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 28 9 -28 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (Ho mo salate - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

3.5 g in 50 mL

O ctisa la te (UNII: 4X49 Y0 59 6 W) (Octisalate - UNII:4X49 Y0 59 6 W)

O c tisa la te

2.5 g in 50 mL

Avo benzo ne (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX)

Avo be nz o ne

1.49 5 g in 50 mL

Ensulizo le (UNII: 9 YQ9 DI1W42) (Ensulizo le - UNII:9 YQ9 DI1W42)

Ensuliz o le

1 g in 50 mL

O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM)

O c to c ryle ne

0 .43 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

C15-19 Alka ne (UNII: CI8 7N1IM0 1)

Ca prylyl Trisilo xa ne (UNII: Q9 5M2P1KJL)

Cetyl Alco ho l (UNII: 9 36 JST6 JCN)

Rice Bra n O il (UNII: LZO6 K150 6 A)

Sa ccha ride Iso mera te (UNII: W8 K377W9 8 I)

Cellulo se Aceta te (UNII: 3J2P0 7GVB6 )

Cetra ria Isla ndica Subsp. Isla ndica (UNII: BJ7YPN79 A1)

Alla nto in (UNII: 344S277G0 Z)

.Alpha .-To co phero l (UNII: H4N8 55PNZ1)

Da te (UNII: H3O7QI5HY7)

Fo lic Acid (UNII: 9 35E9 7BOY8 )

Pa lmito yl Tetra peptide-7 (UNII: Q41S46 4P1R)

Pa lmito yl Tripeptide-1 (UNII: RV743D216 M)

Ga la cto a ra bina n (UNII: SL4SX1O48 7)

Sunflo wer O il (UNII: 3W1JG79 5YI)

Glyceryl Mo no stea ra te (UNII: 230 OU9 XXE4)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Amino methylpro pa no l (UNII: LU49 E6 6 26 Q)

Bo ro n Nitride (UNII: 2U4T6 0 A6 YD)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Ceteth-2 0 (UNII: I8 35H2IHHX)

Stea reth-2 0 (UNII: L0 Q8 IK9 E0 8 )

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

PEG-7 5 Stea ra te (UNII: OT38 R0 N74H)

Chlo rphenesin (UNII: I6 70 DAL4SZ)

AHAVA Dead Sea Laboratories Ltd

Xa ntha n Gum (UNII: TTV12P4NEE)

Edeta te Diso dium Anhydro us (UNII: 8 NLQ36 F6 MM)

Hydro g ena ted Po lydecene ( 550 MW) (UNII: U333RI6 EB7)

Beta sizo fira n (UNII: 2X51AD1X3T)

Pullula n (UNII: 8 ZQ0 AYU1TT)

Ca rbo xypo lymethylene (UNII: 0 A5MM30 7FC)

Gera nio l (UNII: L8 3710 8 USY)

.Beta .-Citro nello l, ( R) - (UNII: P0 1OUT9 6 4K)

Co uma rin (UNII: A4VZ22K1WT)

Limo nene, ( +) - (UNII: GFD7C8 6 Q1W)

Lina lo o l, ( +/-) - (UNII: D8 1QY6 I8 8 E)

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

So dium Citra te, Unspecified Fo rm (UNII: 1Q73Q2JULR)

Po lyso rba te 2 0 (UNII: 7T1F30 V5YH)

Po ta ssium So rba te (UNII: 1VPU26 JZZ4)

So dium Benzo a te (UNII: OJ245FE5EU)

LYSO PHO SPHATIDYLCHO LINE, SO YBEAN (UNII: CQD8 3320 4Z)

ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)

LYCIUM BARBARUM FRUIT (UNII: 9 30 6 26 MWDL)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 0 28 9 -28 5-

1 in 1 CARTON

0 5/15/20 19

1

50 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 5/15/20 19

Labeler -

AHAVA Dead Sea Laboratories Ltd (600056907)

Revised: 9/2019

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