Label: AHAVA MULTIVITAMIN DAY SPF30- avobenzone, ensulizole, octisalate, and octocrylene cream
- NDC Code(s): 60289-301-24
- Packager: AHAVA - Dead Sea Laboratories Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 6, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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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 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, Glycerin, Stearyl Alcohol, Methyl Methacrylate Crosspolymer, Dimethyl Capramide, C12-15 Alkyl Benzoate, Dimethicone, Potassium Cetyl Phosphate, Cellulose Acetate, PEG-100 Stearate, Hydrogenated Palm Glycerides, Glyceryl Stearate, Aminomethyl Propanol, Phenoxyethanol, Sodium Citrate, Propanediol, Erythritol, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane (Phytosqualane), Hydrolyzed Wheat Protein/PVP Crosspolymer, Caprylic/Capric Triglyceride, Parfum (Fragrance), Hexyl Cinnamal, Limonene, Linalool, Citral, Geraniol, Xanthan Gum, Niacinamide, Disodium EDTA, Chlorphenesin, Hydrogenated Polydecene, Behenyl Behenate, Tribehenin, Citric Acid, Caprylyl Glycol, Didecyldimonium Chloride, Sodium Benzoate, Potassium Sorbate, Ethylhexylglycerin, Homarine HCl, Hydrolyzed Yeast Protein, Usnea Barbata (Lichen) Extract, Acmella Oleracea Extract, Allantoin, Panthenol (Pro Vitamin B5), Ascorbyl Glucoside (Vitamin C derivative), Phoenix Dactylifera (Date) Fruit Extract, Dunaliella Salina (Dead Sea Alga) Extract, Maris Aqua (Dead Sea Water/Osmoter).
- Other information
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
AHAVA MULTIVITAMIN DAY SPF30
avobenzone, ensulizole, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60289-301 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 Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole 30 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 80.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CELLULOSE ACETATE (UNII: 3J2P07GVB6) PEG-100 STEARATE (UNII: YD01N1999R) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) PROPANEDIOL (UNII: 5965N8W85T) ERYTHRITOL (UNII: RA96B954X6) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) CITRAL (UNII: T7EU0O9VPP) GERANIOL (UNII: L837108USY) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CHLORPHENESIN (UNII: I670DAL4SZ) BEHENYL BEHENATE (UNII: K8NU647RJ0) TRIBEHENIN (UNII: 8OC9U7TQZ0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) USNEA BARBATA (UNII: D6DVA9TCAP) ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) DATE (UNII: H3O7QI5HY7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60289-301-24 1 in 1 CARTON 02/25/2023 1 50 mL in 1 JAR; 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 02/25/2023 Labeler - AHAVA - Dead Sea Laboratories Ltd (600056907)