Label: PEACH TANNING OIL SPF6- octocrylene, octinoxate, avobenzone oil
- NDC Code(s): 70630-0028-1
- 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 28, 2022
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- Product Information / Drug Facts
- Directions:
- Warnings / Cautions / Sun safety:
- Use:
- Active ingredients:
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Inactive ingredients:
Prunus Amygdalus Dulcis (Sweet Almond) Oil,Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Octocrylene, Ethylhexyl Methoxycinnamate, Hydrogenated Soy Polyglycerides, Prunus Persica (Peach) Kernel Oil, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, Natural Peach Fragrance, C15-23 Alkane, BHT, Benzyl Alcohol.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PEACH TANNING OIL SPF6
octocrylene, octinoxate, avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 25 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 25 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) GRAPE SEED OIL (UNII: 930MLC8XGG) COCONUT OIL (UNII: Q9L0O73W7L) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PERSIC OIL (UNII: 5M26W7T072) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) C15-23 ALKANE (UNII: J3N6X3YK96) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0028-1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/28/2022 Labeler - Bali Body Pty Ltd (757840223)