Label: AVAIL BODY WITH SUNSCREEN- homosalate, octocrylene, octisalate, and avobenzone lotion
- NDC Code(s): 76293-015-02, 76293-015-15
- Packager: Emeis Cosmetics Pty 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 May 4, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply
- At least every 2 hours
- Immediately after swimming, sweating, or towel drying.
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months of age: Ask a doctor.
- Other information
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Inactive ingredients
Water ( Aqua), C12-15 Alkyl Benzoate, Euphorbia Cerifera ( Candelilla) Wax, Silica, Triacontanyl PVP, PEG-15 Cocamine, Glyceryl Behenate, Panthenol, PEG-40 Stearate, Lavandula Angustifolia ( Lavender) Oil, Caprylyl Glycol, Mentha Viridis ( Spearmint) Leaf Oil, Acrylates/Steareth-20 Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylhydroxamic Acid, Glycerin, Citrus Medica Limonum ( Lemon) Peel Oil, Persea Gratissima ( Avocado) Oil, Prunus Amygdalus Dulcis ( Sweet Almond ) Oil, Simmondsia Chinensis ( Jojoba) Seed Oil, Methyl Glucose Sesquistearate, Glycine Soja ( Soybean) Oil, Tocopheryl Acetate, Beta-Carotene, Daucus Carota ( Carrot) Sativa Root Extract, Tocopherol, Linalool, Limonene, Citral, Geraniol.
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Product Packaging
Aēsop ®
SPF
50
Avail Body Lotion
with SunscreenSpearmint Leaf • Panthenol • Tocopherol
Broad-spectrum SPF50
High protection, Broad-spectrum moisturising sunscreen with a lightweight skin feel and refreshing aroma.
Massage generously into uncovered skin fifteen minutes prior to sun exposure.
To maintain protection, reapply at least every two hours, and after perspiring, swimming or towelling dry.
www.aesop.com
Net Wt. 145.5 g / 5.13 oz.
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INGREDIENTS AND APPEARANCE
AVAIL BODY WITH SUNSCREEN
homosalate, octocrylene, octisalate, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76293-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3500 mg in 35 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2800 mg in 35 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1750 mg in 35 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1050 mg in 35 g Inactive Ingredients Ingredient Name Strength LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) CITRAL (UNII: T7EU0O9VPP) GERANIOL (UNII: L837108USY) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) CANDELILLA WAX (UNII: WL0328HX19) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-15 COCAMINE (UNII: 8L6LB12TSJ) ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) PEG-40 STEARATE (UNII: ECU18C66Q7) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) PANTHENOL (UNII: WV9CM0O67Z) LAVENDER OIL (UNII: ZBP1YXW0H8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SPEARMINT OIL (UNII: C3M81465G5) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) LEMON OIL (UNII: I9GRO824LL) AVOCADO OIL (UNII: 6VNO72PFC1) ALMOND OIL (UNII: 66YXD4DKO9) JOJOBA OIL (UNII: 724GKU717M) SOYBEAN OIL (UNII: 241ATL177A) METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) CARROT (UNII: L56Z1JK48B) .BETA.-CAROTENE (UNII: 01YAE03M7J) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76293-015-15 1 in 1 CARTON 11/04/2014 01/15/2023 1 152.4 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:76293-015-02 1 in 1 CARTON 05/17/2021 2 145.5 g in 1 BOTTLE, PUMP; 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 11/04/2014 Labeler - Emeis Cosmetics Pty Ltd (754271146)