Label: BALI BODY BB CREAM SPF 15 NATURAL- octocrylene, octinoxate, avobenzone, oxybenzone cream
- NDC Code(s): 70630-0029-1
- 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 March 25, 2022
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- Product Information / Drug Facts
- Directions:
- Warnings:
- Use:
- Active ingredients:
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Inactive ingredients:
Water (Aqua), Propylene Glycol, Cyclopentasiloxane, Ethylhexyl Stearate, Glyceryl Stearate, Cetearyl Alcohol, Tapioca Starch, Vitis Vinifera (Grape) Seed Oil, Cyclohexasiloxane, Potassium Cetyl Phosphate, Glycerin, CI 77891, Cetearyl Olivate, Sorbitan Olivate, Phenoxyethanol, Mica, Benzyl Alcohol, Ethylhexylglycerin, Phytic Acid, Butylene Glycol, Sodium Hydroxide, Hydrolyzed Collagen, Sodium Hyaluronate, Acanthopanax Senticosus Root Extract, Camellia Sinensis Leaf Extract, Alcohol, Fragrance (Parfum), Potassium Sorbate, CI 77492, CI 77491, CI 77499.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
BALI BODY BB CREAM SPF 15 NATURAL
octocrylene, octinoxate, avobenzone, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0029 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength FYTIC ACID (UNII: 7IGF0S7R8I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GRAPE SEED OIL (UNII: 930MLC8XGG) STARCH, TAPIOCA (UNII: 24SC3U704I) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETEARYL OLIVATE (UNII: 58B69Q84JO) GLYCERIN (UNII: PDC6A3C0OX) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ELEUTHERO (UNII: ZQH6VH092Z) SORBITAN OLIVATE (UNII: MDL271E3GR) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ALCOHOL (UNII: LKG8494WBH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0029-1 1 in 1 BOX 03/25/2022 1 35 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 not final part352 03/25/2022 Labeler - Bali Body Pty Ltd (757840223)