Bali Body Tinted Super Serum Spf 30

Bali Body Tinted Super Serum Spf 30
SPL v3
SPL
SPL Set ID f5eeaf37-33f2-2c0c-e053-2a95a90abcc0
Route
TOPICAL
Published
Effective Date 2023-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (78 mg) Octisalate (49 mg) Titanium Dioxide (31 mg) Zinc Oxide (56 mg)
Inactive Ingredients
Dimethiconol (2000 Cst) Sodium Stearoyl Glutamate Orange Oil Hydrogen Dimethicone (13 Cst) .alpha.-tocopherol Acetate Glutamic Acid Sodium Chloride Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane Alkyl (c12-15) Benzoate Lauryl Peg/ppg-18/18 Methicone Cyclomethicone 5 Hyaluronic Acid Silicon Dioxide Ethylhexylglycerin Aspartic Acid Leucine Lysine Phenylalanine Jojoba Oil, Randomized Mica Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Peg/ppg-18/18 Dimethicone Dimethicone Medium-chain Triglycerides Pentylene Glycol Frankincense Oil Stannous Oxide Glycerin Glycine Ferric Oxide Yellow Caprylyl Trisiloxane Water Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Ferric Oxide Red Alanine Tyrosine Proline Arginine Isoleucine Threonine Valine Histidine Ferrosoferric Oxide Limonene, (+)- Caprylyl Glycol Phenoxyethanol Serine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-31

Description

Octisalate 3.1% Octocrylene 8.1% Titanium Dioxide 3.2% Zinc Oxide 5.9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octisalate 3.1% Octocrylene 8.1% Titanium Dioxide 3.2% Zinc Oxide 5.9%

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
Warnings

For external use only.

Directions
  • Apply liberally 15 mins before sun exposure.
  • Shake well to activate.
  • Apply 2-3 drops onto your fingertips & blend evenly all over the face & neck.
  • Reapply at least every 2 hours
  • Use 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 this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10am - 2pm
  • Wear long sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor.
Do Not Use

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
  • Keep out of direct sunlight or other sources of strong light.
  • Product to be stored between 5-28C/41-82F.
  • Report serious adverse events to: AMS Fulfillment, 29010 Commerce Centre Drive, Valencia CA, 1935
When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Product Packaging Tan Shade

Active Ingredients Tan Shade

Octisalate 4.9%

Octocrylene 7.8%

Titanium Dioxide 3.1%

Zinc Oxide 5.6%

Keep Out of Reach of Children.

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.

Inactive Ingredients Tan Shade

Water (Aqua), Caprylyl Methicone, C12-15 Alkyl Benzoate, Lauryl PEG/PPG-18/18 Methicone, Dimethicone, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Polyhydroxystearic Acid, Sodium Chloride, Dimethiconol, Jojoba Esters, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica, PEG/PPG-18/18 Dimethicone, Polyglyceryl-3 Beeswax, Triethoxycaprylylsilane, Sodium Stearoyl Glutamate, Hydrogen Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Oil, Boswellia Carterii Oil, Tin Oxide, Limonene, Caprylyl Glycol, Hyaluronic Acid, Glycerin, Tocopheryl Acetate, Phenoxyethanol, Diaminopropionoyl Tripeptide-33, Ethylhexylglycerin, Glycine, Glutamic Acid, Serine, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Phenylalanine, Tyrosine, Isoleucine, Proline, Threonine, Valine, Histidine, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Product Packaging Natural Shade

Active Ingredients: Natural Shade

Octisalate 3.1%

Octocrylene 8.1%

Titanium Dioxide 3.2%

Zinc Oxide 5.9%

Inactive Ingredients Natural Shade

Caprylyl Methicone, Water (Aqua), C12-15 Alkyl Benzoate, Lauryl PEG/PPG-18/18 Methicone, Dimethicone, Caprylic/Capric Triglyceride, Pentylene Glycol, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Dimethiconol, Sodium Chloride, Polyhydroxystearic Acid, Jojoba Esters, Silica, Mica, Polyglyceryl-3 Beeswax, Triethoxycaprylylsilane, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Sodium Stearoyl Glutamate, Citrus Aurantium Dulcis (Orange) Peel Oil, Boswellia Carterii Oil, Hydrogen Dimethicone, Tin Oxide, Limonene, Caprylyl Glycol, Glycerin, Hyaluronic Acid, Phenoxyethanol, Tocopheryl Acetate, Ethylhexylglycerin, Diaminopropionoyl Tripeptide-33, Glycine, Glutamic Acid, Serine, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Phenylalanine, Tyrosine, Isoleucine, Proline, Threonine, Valine, Histidine, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)


Structured Label Content

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

Warnings

For external use only.

Directions
  • Apply liberally 15 mins before sun exposure.
  • Shake well to activate.
  • Apply 2-3 drops onto your fingertips & blend evenly all over the face & neck.
  • Reapply at least every 2 hours
  • Use 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 this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10am - 2pm
  • Wear long sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor.
Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
  • Keep out of direct sunlight or other sources of strong light.
  • Product to be stored between 5-28C/41-82F.
  • Report serious adverse events to: AMS Fulfillment, 29010 Commerce Centre Drive, Valencia CA, 1935
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.

Product Packaging Tan Shade (Product Packaging - Tan Shade)

Active Ingredients Tan Shade (Active ingredients - Tan Shade)

Octisalate 4.9%

Octocrylene 7.8%

Titanium Dioxide 3.1%

Zinc Oxide 5.6%

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

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.

Inactive Ingredients Tan Shade (Inactive ingredients - Tan Shade)

Water (Aqua), Caprylyl Methicone, C12-15 Alkyl Benzoate, Lauryl PEG/PPG-18/18 Methicone, Dimethicone, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Polyhydroxystearic Acid, Sodium Chloride, Dimethiconol, Jojoba Esters, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica, PEG/PPG-18/18 Dimethicone, Polyglyceryl-3 Beeswax, Triethoxycaprylylsilane, Sodium Stearoyl Glutamate, Hydrogen Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Oil, Boswellia Carterii Oil, Tin Oxide, Limonene, Caprylyl Glycol, Hyaluronic Acid, Glycerin, Tocopheryl Acetate, Phenoxyethanol, Diaminopropionoyl Tripeptide-33, Ethylhexylglycerin, Glycine, Glutamic Acid, Serine, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Phenylalanine, Tyrosine, Isoleucine, Proline, Threonine, Valine, Histidine, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Product Packaging Natural Shade (Product Packaging - Natural Shade)

Active Ingredients: Natural Shade (Active ingredients:- Natural Shade)

Octisalate 3.1%

Octocrylene 8.1%

Titanium Dioxide 3.2%

Zinc Oxide 5.9%

Inactive Ingredients Natural Shade (Inactive ingredients - Natural Shade)

Caprylyl Methicone, Water (Aqua), C12-15 Alkyl Benzoate, Lauryl PEG/PPG-18/18 Methicone, Dimethicone, Caprylic/Capric Triglyceride, Pentylene Glycol, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Dimethiconol, Sodium Chloride, Polyhydroxystearic Acid, Jojoba Esters, Silica, Mica, Polyglyceryl-3 Beeswax, Triethoxycaprylylsilane, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Sodium Stearoyl Glutamate, Citrus Aurantium Dulcis (Orange) Peel Oil, Boswellia Carterii Oil, Hydrogen Dimethicone, Tin Oxide, Limonene, Caprylyl Glycol, Glycerin, Hyaluronic Acid, Phenoxyethanol, Tocopheryl Acetate, Ethylhexylglycerin, Diaminopropionoyl Tripeptide-33, Glycine, Glutamic Acid, Serine, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Phenylalanine, Tyrosine, Isoleucine, Proline, Threonine, Valine, Histidine, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)


Advanced Ingredient Data


Raw Label Data

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