DailyMed - AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30- avobenzone, ensulizole, octisalate, and octocrylene lotion

NDC Code(s): 60289-306-30
Packager: AHAVA - Dead Sea Laboratories Ltd

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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ACTIVE INGREDIENT
Active ingredientsPurpose - Avobenzone 2.84%sunscreens - Ensulizole 3%sunscreens - Octisalate 5%sunscreens - Octocrylene 7.96%sunscreens

Active ingredients Purpose

Avobenzone 2.84% sunscreens

Ensulizole 3% sunscreens

Octisalate 5% sunscreens

Octocrylene 7.96% sunscreens

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Uses
helps prevent sunburn
- helps prevent sunburn
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Warnings
For External Use Only - Do not use on damaged or broken skin - Stop use and consult a doctor if rash or irritation develops and lasts - When using this product keep out of eyes. Rinse ...

For External Use Only

Do not use on damaged or broken skin

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

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

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

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Directions
apply liberally 15 minutes before sun exposure - use a water resistant sunscreen if swimming or sweating - reapply at least every 2 hours - children under 6 months: Ask a doctor - Sun Protection ...
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
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Inactive Ingredients
Aqua (Mineral Spring Water), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Isodecyl Isononanoate, Dimethyl Capramide, Cellulose Acetate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate ...

Aqua (Mineral Spring Water), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Isodecyl Isononanoate, Dimethyl Capramide, Cellulose Acetate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Glycerin, Phenoxyethanol, Aminomethyl Propanol, Hydrogenated Palm Glycerides, Acacia Senegal Gum, Erythritol, Xanthan Gum, Dimethicone, Parfum (Fragrance), Pinene, Linalool, Limonene, Geranyl Acetate, Geraniol, Citrus Aurantium Peel Oil, Allantoin, Chlorphenesin, Disodium EDTA, Dimethiconol, Caprylyl Glycol, Didecyldimonium Chloride, Potassium Sorbate, Sodium Benzoate, Homarine HCl, Citric Acid, Sorbic Acid, Euterpe Oleracea (Acai) Fruit Extract, Coffea Arabica (Coffee) Seed Extract, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Maris Aqua (Dead Sea Water/ Osmoter).
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Other information
protect this product from excessive heat and direct sun

protect this product from excessive heat and direct sun
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Questions or comments
Call toll free 1-800-366-7254

Call toll free 1-800-366-7254
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PRINCIPAL DISPLAY PANEL - 150 ml Tube Carton
AHAVA - Protecting - Body Lotion Broad - Spectrum SPF 30 - PA +++ BODY ESSENTIAL - HYDRATION

AHAVA

Protecting
Body Lotion Broad
Spectrum SPF 30

PA +++

BODY ESSENTIAL
HYDRATION

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Active ingredients	Purpose
Avobenzone 2.84%	sunscreens
Ensulizole 3%	sunscreens
Octisalate 5%	sunscreens
Octocrylene 7.96%	sunscreens

INGREDIENTS AND APPEARANCE

Product Information

AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30 avobenzone, ensulizole, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60289-306
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.0284 g in 1 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.03 g in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.0796 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Isodecyl Isononanoate (UNII: 4X46Q4U00Z)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
Cellulose Acetate (UNII: 3J2P07GVB6)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Glycerin (UNII: PDC6A3C0OX)
Phenoxyethanol (UNII: HIE492ZZ3T)
Aminomethylpropanol (UNII: LU49E6626Q)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Acacia (UNII: 5C5403N26O)
Erythritol (UNII: RA96B954X6)
Xanthan Gum (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
Pinene (UNII: 996299PUKB)
Linalool, (+/-)- (UNII: D81QY6I88E)
Limonene, (+)- (UNII: GFD7C86Q1W)
Geranyl Acetate (UNII: 3W81YG7P9R)
Geraniol (UNII: L837108USY)
Bitter Orange Oil (UNII: 9TLV70SV6I)
Allantoin (UNII: 344S277G0Z)
Chlorphenesin (UNII: I670DAL4SZ)
Edetate Disodium (UNII: 7FLD91C86K)
Caprylyl Glycol (UNII: 00YIU5438U)
Didecyldimonium Chloride (UNII: JXN40O9Y9B)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
Homarine Hydrochloride (UNII: 8866LNG61N)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sorbic Acid (UNII: X045WJ989B)
Acai (UNII: 46AM2VJ0AW)
Arabica Coffee Bean (UNII: 3SW678MX72)
Aloe Vera Leaf (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60289-306-30	1 in 1 CARTON	03/15/2024
1		150 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	03/15/2024

Labeler - AHAVA - Dead Sea Laboratories Ltd (600056907)

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Label: AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30- avobenzone, ensulizole, octisalate, and octocrylene lotion

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Label: AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30- avobenzone, ensulizole, octisalate, and octocrylene lotion

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AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30- avobenzone, ensulizole, octisalate, and octocrylene lotion

Number of versions: 1

AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30- avobenzone, ensulizole, octisalate, and octocrylene lotion

AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30- avobenzone, ensulizole, octisalate, and octocrylene lotion

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AHAVA PROTECTING BODY BROAD SPECTRUM SPF 30- avobenzone, ensulizole, octisalate, and octocrylene lotion

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.