Balibody Spf15 Bronze Shimmering Tanning Gel

Balibody Spf15 Bronze Shimmering Tanning Gel
SPL v1
SPL
SPL Set ID 28660ce2-6805-41f3-e063-6394a90af45d
Route
TOPICAL
Published
Effective Date 2025-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (7 g) Avobenzone (2 g) Octisalate (5 g)
Inactive Ingredients
Iron Oxides Mica Isochrysis Galbana Whole Stearalkonium Hectorite Mineral Oil Triethanolamine Beta-carotene Bht Bisabolol Sorbitan Stearate Propylene Glycol Xanthan Gum Tocopherol .alpha.-tocopherol Acetate Petrolatum C12-15 Alkyl Benzoate Propylene Carbonate Glycine Soja (soybean) Oil Carrot Caprylic/capric Triglyceride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-10

Description

Active Ingredients: Purpose: Avobenzone 2.0%, Octyl Salicylate 5.0%, Octocrylene 7.0% Sunscreen


Medication Information

Warnings and Precautions

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.

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and 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.

Description

Active Ingredients: Purpose: Avobenzone 2.0%, Octyl Salicylate 5.0%, Octocrylene 7.0% Sunscreen

Section 50565-1

Keep out of reach of children.

Section 51727-6

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.

Section 51945-4

BaliBody

SPF 15 Bronze Shimmering Tanning Gel

150g 5.07fl.oz

Section 55105-1

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.

Section 55106-9

Active Ingredients: Purpose:

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

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

BaliBody

SPF 15 Bronze Shimmering Tanning Gel

150g 5.07fl.oz

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

Active Ingredients: Purpose:

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

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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