bali body spf15 bronze shimmering tanning gel

bali body spf15 bronze shimmering tanning gel
SPL v3
SPL
SPL Set ID 240d4d80-641c-ac57-e063-6394a90abe75
Route
topical
Published
Effective Date 2024-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (70 mg) octisalate (50 mg) avobenzone (20 mg)
Inactive Ingredients
isochrysis galbana whole beta carotene tocopherol .alpha.-tocopherol acetate, dl- sorbitan monostearate butylated hydroxytoluene xanthan gum stearalkonium hectorite soybean oil mica propylene carbonate levomenol propylene glycol carrot petrolatum medium-chain triglycerides mineral oil alkyl (c12-15) benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-01

Purpose

Sunscreen

Description

Avobenzone 2.0% Octisalate 5.0% Octocrylene 7.0%


Medication Information

Warnings
  • For external use only
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.
Purpose

Sunscreen

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 protection measures including
  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor.
Other Information
  • Protect this product from excessive heat and direct sun. Report serious adverse events to: AMS Fulfillment 29010 Commerce Drive, Valencia CA 91355
Inactive Ingredients

Petrolatum, Caprylic/Capric Triglyceride, Mineral Oil, C12-15 Alkyl Benzoate, Sorbitan Stearate, Propylene Glycol, Mica, Stearalkonium Hectorite, Iron Oxides, Propylene Carbonate, Glycine Soja (Soybean) Oil, Fragrance/Parfum, Bisabolol, Xanthan Gum, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Tocopherol, BHT, Tocopheryl Acetate, Isochrysis Galbana Extract.

Description

Avobenzone 2.0% Octisalate 5.0% Octocrylene 7.0%

Do Not Use

on damaged or broken skin

Product Packaging

Active Ingredients:

Avobenzone 2.0%

Octisalate 5.0%

Octocrylene 7.0%

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a poison control centre right away. Please refer to balibody.com for further sun safety instructions.


Structured Label Content

Warnings
  • For external use only
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.
Purpose

Sunscreen

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 protection measures including
  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun. Report serious adverse events to: AMS Fulfillment 29010 Commerce Drive, Valencia CA 91355
Inactive Ingredients (Inactive ingredients)

Petrolatum, Caprylic/Capric Triglyceride, Mineral Oil, C12-15 Alkyl Benzoate, Sorbitan Stearate, Propylene Glycol, Mica, Stearalkonium Hectorite, Iron Oxides, Propylene Carbonate, Glycine Soja (Soybean) Oil, Fragrance/Parfum, Bisabolol, Xanthan Gum, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Tocopherol, BHT, Tocopheryl Acetate, Isochrysis Galbana Extract.

Do Not Use (Do not use)

on damaged or broken skin

Product Packaging

Active Ingredients: (Active ingredients:)

Avobenzone 2.0%

Octisalate 5.0%

Octocrylene 7.0%

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a poison control centre right away. Please refer to balibody.com for further sun safety instructions.


Advanced Ingredient Data


Raw Label Data

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