Label: CANNON BALM 140- octinoxate, avobenzone, octisalate, oxybenzone stick
- NDC Code(s): 71782-140-01
- Packager: DUKE CANNON SUPPLY CO.
- 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 March 16, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings:
For external use only.
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 value 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: ask a doctor
When using this product:
•Keep out of eyes
•Rinse with water to remove
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients:
Organic Baobab Oil, Organic Beeswax, Organic Blood Orange Essential Oil, Organic, Calendula Extract,
Castor Oil, Ceresine Wax, Hydrated Silica, Hydroxystearic/Linoleic/Linolenic/Oleic Polyglycerides,
Natural Flavor, Organic Olive Oil, Organic Peppermint Essential Oil, Polyisobutene, Rice Bran Wax,
Organic Rosemary Extract, Organic Stevia, Organic Tea Tree Essential Oil, Vitamin E.
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CANNON BALM 140
octinoxate, avobenzone, octisalate, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71782-140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.28 g in 17 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.17 g in 17 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.85 g in 17 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.68 g in 17 g Inactive Ingredients Ingredient Name Strength ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I) YELLOW WAX (UNII: 2ZA36H0S2V) ORANGE OIL (UNII: AKN3KSD11B) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CASTOR OIL (UNII: D5340Y2I9G) CERESIN (UNII: Q1LS2UJO3A) HYDRATED SILICA (UNII: Y6O7T4G8P9) 12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) LINOLEIC ACID (UNII: 9KJL21T0QJ) OLEIC ACID (UNII: 2UMI9U37CP) OLIVE OIL (UNII: 6UYK2W1W1E) PEPPERMINT OIL (UNII: AV092KU4JH) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) RICE BRAN (UNII: R60QEP13IC) ROSEMARY OIL (UNII: 8LGU7VM393) STEVIA LEAF (UNII: 6TC6NN0876) TEA TREE OIL (UNII: VIF565UC2G) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71782-140-01 17 g in 1 TUBE; Type 0: Not a Combination Product 09/30/2017 05/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/30/2017 05/01/2024 Labeler - DUKE CANNON SUPPLY CO. (078715221)
