BALIBODY SPF15 BRONZE SHIMMERING TANNING GEL- avobenzone, octisalate, octocrylene gel

BaliBody SPF15 Bronze Shimmering Tanning Gel by

Drug Labeling and Warnings

BaliBody SPF15 Bronze Shimmering Tanning Gel by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Purpose:

Avobenzone 2.0%, Octyl Salicylate 5.0%, Octocrylene 7.0% Sunscreen

PURPOSE

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep ou tof eyes. Rinse with water to remove. If product is swallowed, get medical help or contact a poison control center right away. Please refer to balibodyco.com for further sun safety instructions.

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.

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

Other information: Protect this product from excessive heat and direct sun. Report serious adverse events to: AMS Fullfilment 29010 Commerce Drive, Valencia CA 91355.

PRINCIPAL DISPLAY PANEL

BaliBody

SPF 15 Bronze Shimmering Tanning Gel

150g 5.07fl.oz

INGREDIENTS AND APPEARANCE

BALIBODY SPF15 BRONZE SHIMMERING TANNING GEL 
avobenzone, octisalate, octocrylene gel

Product 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)