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

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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Drug Facts

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

ChapIce Sport SPF 30 Broad Spectrum
CHAPICE SPF 30 LIP BALM 
avobenzone, octisalate, homosalate, petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM396 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63645-180-014.25 g in 1 CONTAINER; Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2022
Labeler - OraLabs (801824756)
Registrant - OraLabs (801824756)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(63645-180) , LABEL(63645-180)

Revised: 9/2022
Document Id: c7094485-a19f-41b7-88b8-d6d472adbff1
Set id: c7094485-a19f-41b7-88b8-d6d472adbff1
Version: 1
Effective Time: 20220921
 
OraLabs