DESIGNER LIP SMOOTHIE SPF 15 LIP BALM- avobenzone, octisalate, homosalate, petrolatum stick

Designer Lip Smoothie SPF 15 Lip Balm by

Drug Labeling and Warnings

Designer Lip Smoothie SPF 15 Lip Balm by is a Otc medication manufactured, distributed, or labeled by Australian Gold, OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%)

Petrolatum (38.8%)

Purpose

Sunscreen, Sunscreen, Skin Protectant

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn. Helps prevent and temporarily protect dry, chapped, or windburned lips.

Warnings

For external use only: When using this product. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut ) Oil, Ethylhexyl Methoxycrylene, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Microcrystalline Wax, Olea Europaea (Olive) Fruit Oil, Ozokerite, Saccharin, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DESIGNER LIP SMOOTHIE SPF 15 LIP BALM 
avobenzone, octisalate, homosalate, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84061-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	388 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)	165 mg  in 1 g
ISOCETYL STEARATE (UNII: 3RJ7186O9W)	23 mg  in 1 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	5 mg  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84061-127-01	3.12 g in 1 CONTAINER; Type 0: Not a Combination Product	08/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2024

Labeler - Australian Gold (073212842)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	manufacture(84061-127) , label(84061-127) , analysis(84061-127)