Label: CANNACELL SUN BUDDY FACIAL SPF 30- zinc oxide lotion
- NDC Code(s): 55560-1812-1
- Packager: Andalou naturals
- 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 January 17, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
- Daily, alone or under make-up.
- Apply liberally 15 minutes before sun exposure and as needed.
- Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
- Use water resistant sunscreen if swimming or sweating.
- 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 10am-2pm, wear long sleeve shirts, pants and sunglasses.
- Children under 6 months: ask a doctor.
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Inactive Ingredients
Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, Vegetable Glycerin, Hydrogenated Castor Oil, Sorbitan Sesquioleate, Hydrogenated Methyl Abietate, Magnesium Sulfate, Stearyl/Octyldodecyl Citrate Crosspolymer, Cannabis Sativa (Hemp) Seed Oil1, Magnesium Ascorbyl Phosphate (Vitamin C), Cannabis Sativa (Hemp) Cell Culture Extract, Resveratrol, Simmondsia Chinensis (Jojoba) Seed Oil1, Allantoin, Phenoxyethanol, Ethylhexylglycerin, Tocopherol, Citrus Tangerina (Tangerine) Peel Oil1, Citrus Aurantium (Petitgrain) Flower Oil1, Anthemis Nobilis (Roman Chamomile) Flower Oil, Citral2, Limonene2, Linalool2
- Other Information
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CANNACELL SUN BUDDY FACIAL SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55560-1812 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) OCTYLDODECYL STEARATE (UNII: K6F16QGO28) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) CANNABIS SATIVA WHOLE (UNII: B5ONF538PB) RESVERATROL (UNII: Q369O8926L) JOJOBA OIL (UNII: 724GKU717M) ALLANTOIN (UNII: 344S277G0Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) MANDARIN OIL (UNII: NJO720F72R) CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55560-1812-1 1 in 1 CARTON 06/01/2018 1 92 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 06/01/2018 Labeler - Andalou naturals (011472720) Establishment Name Address ID/FEI Business Operations Sun Deep Inc 189788201 MANUFACTURE(55560-1812)
