Coconut Lip Balm SPF15 by Bali Body Pty Ltd Coconut Lip Balm SPF15

Coconut Lip Balm SPF15 by

Drug Labeling and Warnings

Coconut Lip Balm SPF15 by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COCONUT LIP BALM SPF15- octisalate, homosalate, octocrylene, avobenzone lipstick 
Bali Body Pty Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Coconut Lip Balm SPF15

Product Information / Drug Facts

Directions:

Apply to clean lips for long lasting hydration and a dewy glow

Warnings:

For external use only. Keep out of direct sunlight or other sources of strong light. Product to be stored beteen 5-28°C. Discontinues use if irritation occurs. Subtle variations in appearance and texture of this product in no way affect its integrity.

Keep out of reach of children.

Please refer to balibodyco.com for further sun-safety instructions.

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

Octisalate 2.8%
Homosalate 2.8%
Octocrylene 2.8%
Avobenzone 2%

Purpose:

Sunsreen

Inactive ingredients:

Ricinus Communis (Castor) Seed Oil, Hydrogenated Soybean Oil, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Euphorbia Cerifera (candelilla) Wax, Water (Aqua), Simmondsia Chinesis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Vanilla Planifolia Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Daucus Carota Sativa (Carrot) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol, Xanthan Gum, Flavor (Aroma), Stevioside, Polyglyceryl-3 Diisostearate, Potassium Sorbate, Citric Acid, Sodium Hydroxide, Alcohol, Annatto(CI 75120)

Package Labeling:

COCONUT LIP BALM SPF15 
octisalate, homosalate, octocrylene, avobenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	28 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	28 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	28 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
COCONUT OIL (UNII: Q9L0O73W7L)
COCOA BUTTER (UNII: 512OYT1CRR)
CANDELILLA WAX (UNII: WL0328HX19)
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
SOYBEAN OIL (UNII: 241ATL177A)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
CHAMOMILE (UNII: FGL3685T2X)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
STEVIOSIDE (UNII: 0YON5MXJ9P)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
ANNATTO (UNII: 6PQP1V1B6O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0014-1	1 in 1 BOX	01/01/2021
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2021	11/03/2022

Labeler - Bali Body Pty Ltd (757840223)

Revised: 11/2022

Document Id: ec92a1e6-be35-6eb8-e053-2995a90a1d85

34390-5

Set id: 9b8cce1d-cfbd-4ca7-a59e-c3609d4da26c

Version: 3

Effective Time: 20221103