Label: CHAPICE ORIGINAL SPF 4 LIP BALM- padimate o, petrolatum stick
- NDC Code(s): 63645-130-02
- Packager: OraLabs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 27, 2022
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- Active ingredient
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INGREDIENTS AND APPEARANCE
CHAPICE ORIGINAL SPF 4 LIP BALM
padimate o, petrolatum stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63645-130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 44.0 mg in 1 g PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg in 1 g LANOLIN (UNII: 7EV65EAW6H) 1 mg in 1 g CERESIN (UNII: Q1LS2UJO3A) 17.30 mg in 1 g CARNAUBA WAX (UNII: R12CBM0EIZ) 1 mg in 1 g ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 2.23 mg in 1 g LIGHT MINERAL OIL (UNII: N6K5787QVP) 27.50 mg in 1 g Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63645-130-02 1 g in 1 CONTAINER; Type 0: Not a Combination Product 03/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/15/2013 Labeler - OraLabs (801824756) Registrant - OraLabs (801824756) Establishment Name Address ID/FEI Business Operations OraLabs 801824756 MANUFACTURE(63645-130) , LABEL(63645-130)