Label: PINEAPPLE TANNING OIL SPF15- octocrylene, octinoxate, avobenzone oil
- NDC Code(s): 70630-0008-1
- Packager: Bali Body Pty Ltd
- 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 6, 2021
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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, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cocos Nucifera(Coconut) Oil, Octocrylene, Ethylhexyl Methoxycinnamate,Dicaprylyl Carbonate, Hydrogenated Soy Polyglycerides, Butyl Methoxydibenzoylmethane, Ananas Sativus (Pineapple) Fruit Extract, Glycine Soja (Soybean)Oil,Tocopherol, BHT, Natural Pineapple Fragrance, C15-23 Alkane.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PINEAPPLE TANNING OIL SPF15
octocrylene, octinoxate, avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength GRAPE SEED OIL (UNII: 930MLC8XGG) ALMOND OIL (UNII: 66YXD4DKO9) COCONUT OIL (UNII: Q9L0O73W7L) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PINEAPPLE (UNII: 2A88ZO081O) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) C15-23 ALKANE (UNII: J3N6X3YK96) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0008-1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2021 Labeler - Bali Body Pty Ltd (757840223)