ChapIce SPF 30 Lip Balm: Package Insert and Label Information

CHAPICE SPF 30 LIP BALM- octisalate, avobenzone, petrolatum and homosalate 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.

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. Sun Protection Measures. 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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 g
PETROLATUM (PETROLATUM) PETROLATUM 396 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 80 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CERESIN 165 mg in 1 g
ISOCETYL STEARATE 23 mg in 1 g
.ALPHA.-TOCOPHEROL ACETATE 5 mg in 1 g
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63645-180-01 4.25 g in 1 CONTAINER None
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 Operations
OraLabs 801824756 MANUFACTURE (63645-180), LABEL (63645-180)

Revised: 09/2022 OraLabs

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