Label: BALI BODY CACAO TANNING OIL SPF6- octocrylene, octinoxate, avobenzone oil
- NDC Code(s): 70630-0023-1
- Packager: Bali Body Pty Ltd
- 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 February 20, 2022
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- Product Information / Drug Facts
- Directions:
- Warnings / Cautions / Sun safety:
- Use:
- Active ingredients:
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Inactive ingredients:
Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil, Theobroma Cacao (Cocoa) Seed Butter, Dicaprylyl Carbonate, Hydrogenated Soy Polyglycerides, Octocrylene, Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, C15-23 Alkane, BHT.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
BALI BODY CACAO TANNING OIL SPF6
octocrylene, octinoxate, avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0023 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 10 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength GRAPE SEED OIL (UNII: 930MLC8XGG) COCONUT OIL (UNII: Q9L0O73W7L) OLIVE OIL (UNII: 6UYK2W1W1E) COCOA (UNII: D9108TZ9KG) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) C15-23 ALKANE (UNII: J3N6X3YK96) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0023-1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/20/2022 Labeler - Bali Body Pty Ltd (757840223)