bali body cacao tanning oil spf 15

bali body cacao tanning oil spf 15
SPL v2
SPL
SPL Set ID 03c0b83d-0d85-9e69-e063-6394a90a6142
Route
topical
Published
Effective Date 2020-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (90 mg) octisalate (50 mg) avobenzone (30 mg)
Inactive Ingredients
silicon dioxide cocoa butter grape seed oil olive oil coconut oil dicaprylyl carbonate soybean oil tocopherol vinylpyrrolidone/hexadecene copolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-01

Purpose

Sunscreen

Description

Octocrylene 9% Octisalate 5% Avobenzone 3%


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

Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • Protect this product from excessive heat and direct sun
  • Report serious adverse events to: AMS Fulfilment, 29010 Commerce Drive, Valencia CA 91355
Inactive Ingredients

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Olea Europaea Fruit Oil, Theobroma Oil, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Silica, Tocopherol, Glycine Soja Oil.

Description

Octocrylene 9% Octisalate 5% Avobenzone 3%

Drug Facts

Do Not Use 

on damaged or broken skin. 

Package Labeling

Active Ingredients

Octocrylene 9%

Octisalate 5%



Avobenzone 3%

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

Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information (Other information)
  • Protect this product from excessive heat and direct sun
  • Report serious adverse events to: AMS Fulfilment, 29010 Commerce Drive, Valencia CA 91355
Inactive Ingredients (Inactive ingredients)

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Olea Europaea Fruit Oil, Theobroma Oil, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Silica, Tocopherol, Glycine Soja Oil.

Drug Facts

Do Not Use  (Do not use )

on damaged or broken skin. 

Package Labeling

Active Ingredients (Active ingredients)

Octocrylene 9%

Octisalate 5%



Avobenzone 3%

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.


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Raw Label Data

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