Label: ALBA BOTANICA NATURAL EVEN ADVANCED SEA MOSS MOISTURIZER SPF15- homosalate, octocrylene, ethylhexyl salicylate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2312-2 - Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 18, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Apply daily to clean face and neck. Apply at least 15 minutes before and every 2 hours during sun exposure. Children under 6 months: ask a doctor.
Skin protection measures: 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 and early skin aging.
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INACTIVE INGREDIENT
Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate SE, Cetearyl Olivate, Sorbitan Olivate, VP/Hexadecene Copolymer, Hydrogenated Palm Kernel Oil, Aloe Barbadensis Leaf Juice (1), Chondrus Crispus (Sarrageenan) Extract (1) (2), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Laminaria Digitata Extract, Macrocystis Purifera Extract, Spirulina Maxima Extract, Ulva Lactuca Extract (1), Cetyl Alcohol, Allantoin Ascorbic Acid, Ascorbyl Glucoside, Carthamus Tinctorius (Safflower) Oleosomes, Diacetyl Boldine, Erythritol, Homarine HCl, Montmorillonite, Panthenol ,Sodium Stearoyl Glutamate, Ethylhexylglycerin, Gluconolactone, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Benzyl Benzoate, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum).
(1) Certified Organic Ingredient(2) Sea Moss Extract
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA NATURAL EVEN ADVANCED SEA MOSS MOISTURIZER SPF15
homosalate, octocrylene, ethylhexyl salicylate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHONDRUS CRISPUS (UNII: OQS23HUA1X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) CETYL ALCOHOL (UNII: 936JST6JCN) LAMINARIA DIGITATA (UNII: 15E7C67EE8) SPIRULINA MAXIMA (UNII: 9K7IG15M0Q) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) ULVA LACTUCA (UNII: PHR3P25W6Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) ALLANTOIN (UNII: 344S277G0Z) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) DIACETYL BOLDINE (UNII: 37727Z7M0I) ERYTHRITOL (UNII: RA96B954X6) HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) MONTMORILLONITE (UNII: A585MN1H2L) PANTHENOL (UNII: WV9CM0O67Z) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCONOLACTONE (UNII: WQ29KQ9POT) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL BENZOATE (UNII: N863NB338G) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2312-2 1 in 1 CARTON 1 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/02/2011 Labeler - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture