Country: United States
Language: English
Source: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)
OraLabs
PETROLATUM
PETROLATUM 44.0 mg in 1 g
TOPICAL
OTC DRUG
Sunscreen, Skin Protectant Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.
OTC monograph not final
CHAPICE ORIGINAL SPF 4 LIP BALM- PADIMATE O, 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._ ---------- DRUG FACTS ACTIVE INGREDIENT Padimate O, Petrolatum PURPOSE 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. Helps prevent and temporarily protects dry, chapped or windburned lips. WARNINGS Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging. For external use only Stop use and ask a doctor: If rash or irritation develops and lasts. DIRECTIONS Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use. INACTIVE INGREDIENTS Mineral Oil, Ozokerite, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850). Red 6 Lake (CI 15850). PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CHAPICE ORIGINAL SPF 4 LIP BALM padimate o, petrolatum stick PRODUCT 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: 0RE Read the complete document