Label: THE BOD GUARD INVISIBLE SUNSCREEN FOR BODY- avobenzone, homosalate, octisalate, and octocrylene gel
- NDC Code(s): 82757-101-01
- Packager: Dune Suncare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 14, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- apply liberally and evenly 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating.
- at least every 2 hours
- children under 6 months of age: Ask a doctor
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 10a.m.-2p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Other Information
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Inactive ingredients
Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Trisiloxane, Alcohol, Dimethicone, 1,2-Hexanediol, Glycerin, Sodium Polycryloyldimethyl Taurate, Brassica Glycerides, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysilicone-11, Disodium EDTA, Erythritol, Fragrance, Tocopheryl Acetate, Butylene Glycol, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Hibiscus Sabdariffa Fruit Extract, Decyl Glucoside, t-Butyl Alcohol, Denatonium Benzoate
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 250 ML Bottle Label
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INGREDIENTS AND APPEARANCE
THE BOD GUARD INVISIBLE SUNSCREEN FOR BODY
avobenzone, homosalate, octisalate, and octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82757-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.02 g in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.055 g in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.045 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.04 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Dimethicone (UNII: 92RU3N3Y1O) Propanediol (UNII: 5965N8W85T) Alcohol (UNII: 3K9958V90M) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) TRISILOXANE (UNII: 9G1ZW13R0G) 1,2-Hexanediol (UNII: TR046Y3K1G) Glycerin (UNII: PDC6A3C0OX) Aminomethylpropanol (UNII: LU49E6626Q) Caprylhydroxamic Acid (UNII: UPY805K99W) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Erythritol (UNII: RA96B954X6) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Butylene Glycol (UNII: 3XUS85K0RA) Decyl Glucoside (UNII: Z17H97EA6Y) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82757-101-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/07/2022 Labeler - Dune Suncare, Inc. (049095642) Establishment Name Address ID/FEI Business Operations Vegelabs 117878620 MANUFACTURE(82757-101)
