Label: BU SPF 30 BROAD SPECTRUM ALCOHOL-FREE PERFORMANCE SUNSCREEN - NATURAL WHITE SAGE SCENT- octinoxate, octocrylene, octisalate, and avobenzone spray
- NDC Code(s): 70325-3002-1, 70325-3002-3
- Packager: Bu Brands, LLC
- 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 December 20, 2022
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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
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reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Do not spray directly onto the face. Spray into hands, and apply to the face.
- children under 6 months: Ask a doctor
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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 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
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Inactive Ingredients
Cyclopentasiloxane, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Diphenylsiloxy Phenyl Trimethicone, VP/Hexadecene Copolymer (and) Octyldodecanol, Polybutene, Tocopherols, Bisabolol, Lavendula Angustifolia Oil, Citrus Aurantium Bergamia (Bergamot) Fruit, Salvia Officinalis (Sage) Oil and Santalum Album (Sandlewood) Oil.
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 98 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
BU SPF 30 BROAD SPECTRUM ALCOHOL-FREE PERFORMANCE SUNSCREEN - NATURAL WHITE SAGE SCENT
octinoxate, octocrylene, octisalate, and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70325-3002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) LAVENDER OIL (UNII: ZBP1YXW0H8) BERGAMOT OIL (UNII: 39W1PKE3JI) SAGE OIL (UNII: U27K0H1H2O) SANDALWOOD OIL (UNII: X7X01WMQ5F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70325-3002-3 98 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/01/2016 2 NDC:70325-3002-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2016 Labeler - Bu Brands, LLC (080075929) Establishment Name Address ID/FEI Business Operations Westwood Laboratories,Inc. 832280635 MANUFACTURE(70325-3002)
