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NDC 63645-0180-01 ChapIce SPF 30 Lip Balm 30; 80; 50; 396 mg/g; mg/g; mg/g; mg/g Details
ChapIce SPF 30 Lip Balm 30; 80; 50; 396 mg/g; mg/g; mg/g; mg/g
ChapIce SPF 30 Lip Balm is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; PETROLATUM.
Product Information
| NDC | 63645-0180 |
|---|---|
| Product ID | 63645-180_c7094485-a19f-41b7-88b8-d6d472adbff1 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | ChapIce SPF 30 Lip Balm |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Avobenzone, Octisalate, Homosalate, Petrolatum |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | STICK |
| Route | TOPICAL |
| Active Ingredient Strength | 30; 80; 50; 396 |
| Active Ingredient Units | mg/g; mg/g; mg/g; mg/g |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; PETROLATUM |
| Labeler Name | OraLabs |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63645-0180-01 (63645018001)
| NDC Package Code | 63645-180-01 |
|---|---|
| Billing NDC | 63645018001 |
| Package | 4.25 g in 1 CONTAINER (63645-180-01) |
| Marketing Start Date | 2022-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c7094485-a19f-41b7-88b8-d6d472adbff1 Details
Keep Out of Reach of Children
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
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.
INGREDIENTS AND APPEARANCE
| CHAPICE SPF 30 LIP BALM
avobenzone, octisalate, homosalate, petrolatum stick |
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| Labeler - OraLabs (801824756) |
| Registrant - OraLabs (801824756) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| OraLabs | 801824756 | MANUFACTURE(63645-180) , LABEL(63645-180) | |