Label: BALIBODY SPF15 BRONZE SHIMMERING TANNING GEL- avobenzone, octisalate, octocrylene gel
- NDC Code(s): 70157-024-01
- Packager: Baxter Laboratories Pty. Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 3, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Apply liberally 15 minutes before sun exposure. Re-apply your BB at least every 2 hours. Wear a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protective measures including. Limit time in the sun, especially from 10am-2pm. Wear long sleeved shirts, parts, hats and sunglasses. Children under 6 months of age: Ask a doctor.
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INACTIVE INGREDIENT
Inactive ingredients: Petrolatum, Caprylic/Capric Triglyceride, Mineral Oil, C12-15 Alkyl Benzoate, Sorbitan Stearate, Propylene Glycol, Mica, Stearalkonium Hectorite, Iron Oxides, Xanthan Gum, Triethanolamine, Propylene Carbonate, Glycine Soja (Soybean) Oil, Fragrance/Parfum, Bisabolol, Beta-Carolene, Daucus Carota Sativa (Carrot) Root Extract, Tocopherol, BHT, Tocopheryl Acetate, Isochrysis Galbana Extract.
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BALIBODY SPF15 BRONZE SHIMMERING TANNING GEL
avobenzone, octisalate, octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70157-024 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength IRON OXIDES (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) ISOCHRYSIS GALBANA WHOLE (UNII: H22FH39EGN) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) MINERAL OIL (UNII: T5L8T28FGP) TRIETHANOLAMINE (UNII: 9O3K93S3TK) BETA-CAROTENE (UNII: 01YAE03M7J) BHT (UNII: 1P9D0Z171K) BISABOLOL (UNII: 24WE03BX2T) SORBITAN STEARATE (UNII: NVZ4I0H58X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) XANTHAN GUM (UNII: TTV12P4NEE) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PETROLATUM (UNII: 4T6H12BN9U) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) PROPYLENE CARBONATE (UNII: 8D08K3S51E) GLYCINE SOJA (SOYBEAN) OIL (UNII: 241ATL177A) CARROT (UNII: L56Z1JK48B) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70157-024-01 150 g in 1 JAR; Type 0: Not a Combination Product 01/10/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/10/2025 Labeler - Baxter Laboratories Pty. Ltd. (740537709)
