AHAVA ACTIVE DEADSEA MINERALS TIME TO HYDRATE ESSENTIAL LIP BALM BROAD SPECTRUM SPF15

Drug Labeling and Warnings

Drug Details [pdf]

AHAVA ACTIVE DEADSEA MINERALS  TIME TO HYDRATE ESSENTIAL LIP BALM BROAD SPECTRUM SPF15- avobenzone, octisalate, and octocrylene cream 
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.

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AHAVA ACTIVE DEADSEA MINERALS
TIME TO HYDRATE ESSENTIAL LIP BALM BROAD SPECTRUM SPF15

Drug Facts

Active ingredients	Purpose
Avobenzone [3%]	sunscreens
Octisalate [5%]	sunscreens
Octocrylene [2.7%]	sunscreens

Uses

• helps prevent sunburn

Warnings

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 Centre right away.

Directions

• apply liberally and evenly 15 minutes before sun exposure and at least every 2 hours. Use a water resistant sunscreen if swimming.
• 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.-2p.m.
• wear long-sleeved shirts, pants, hats and sunglasses

Other information

• Protect the product in this container from excessive heat and direct sun

Questions or comments

Call toll free 1-800-366-7254

Inactive ingredients

Vegetable (Olus) Oil, Butyloctyl Salicylate, Ethylhexyl Salicylate, Hydrogenated Soy Polyglycerides & C15-23 Alkane, Polyamide-8, Butyl Methoxydibenzoylmethane, Octocrylene, Octyldodecyl Neopentanoate, C30-45Alkyldim ethylsilylPolypropylsilsesquioxan e, Caprylyl Glycol & Chlorphenesin & Phenoxyethanol, Parfum (Fragrance), Bisabolol, Helianthus Annuus (Sunflower) Seed Oil & Aqua (Water) & Ascorbic Acid & Melissa Officinalis Leaf Extract & Polyglyceryl-3 polyricinoleate, Raspberry Seed Oil /Tocopheryl Succinate Aminopropanediol Esters, Porphyra Umbilicalis Extract, Glycerin & Opuntia Ficus- Indica Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Pseudoalteromonas Ferment Extract & Salicylic Acid, Maris Aqua (Dead Sea Water), Commiphora Abyssinica Resin Extract.

PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton

AHAVA
ACTIVE DEADSEA MINERALS

TIME TO HYDRATE

ESSENTIAL LIP BALM
BROAD SPECTRUM
SPF15

15 ml e 0.5 fl.oz

AHAVA ACTIVE DEADSEA MINERALS   TIME TO HYDRATE ESSENTIAL LIP BALM BROAD SPECTRUM SPF15
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.45 g  in 15 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.75 g  in 15 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.411 g  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Caprylyl Glycol (UNII: 00YIU5438U)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
Levomenol (UNII: 24WE03BX2T)
Sunflower Oil (UNII: 3W1JG795YI)
Water (UNII: 059QF0KO0R)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Melissa Officinalis Leaf (UNII: 50D2ZE9219)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
Glycerin (UNII: PDC6A3C0OX)
Prickly Pear Fruit (UNII: 18V8PAQ629)
Helianthus Annuus Sprout (UNII: 4P26HG1S5W)
Salicylic Acid (UNII: O414PZ4LPZ)
Commiphora Madagascariensis Resin (UNII: WCM0X628RY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-238-19	1 in 1 CARTON	08/08/2013	12/31/2018
1		15 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 final	part352	08/08/2013	12/31/2018

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)

Revised: 9/2019

Document Id: 08292847-0106-4645-80ef-69ed1efe31e6

34390-5

Set id: a89333d4-650e-4c0e-8b17-20993c1c9245

Version: 2

Effective Time: 20190911

 

AHAVA Dead Sea Laboratories Ltd