CHAPICE SPF 30 LIP BALM- avobenzone, octisalate, homosalate, petrolatum stick

ChapIce SPF 30 Lip Balm by

Drug Labeling and Warnings

ChapIce SPF 30 Lip Balm by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Petrolatum (39.6%)

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. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only: Do not use on damaged or broken skin. When using this product. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash occurs

Directions

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. SunProtectionMeasures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, 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, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

CHAPICE SPF 30 LIP BALM 
avobenzone, octisalate, homosalate, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-180
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	396 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: 63645-180-01	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	08/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2022

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-180) , LABEL(63645-180)