Label: CARE ONE ORIGINAL SPF 4 LIP BALM- petrolatum and padimate o stick
- NDC Code(s): 41520-979-02
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
Padimate O, PetrolatumClose
Sunscreen, Skin ProtectantClose
- Keep Out of Reach of Children
If swallowed get medical help or contact a Poison Control Center right away.Close
Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.Close
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.Close
Apply liberally before sun exposure and as needed.
Children under 6 months of age: Ask a doctor before use.Close
- 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).Close
- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
CARE ONE ORIGINAL SPF 4 LIP BALM
padimate o, petrolatum stick
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-979 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (PETROLATUM) PETROLATUM 44.0 mg in 1 g PADIMATE O (PADIMATE O) PADIMATE O 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE WAX 3.00 mg in 1 g LANOLIN 1 mg in 1 g CERESIN 17.30 mg in 1 g CARNAUBA WAX 1 mg in 1 g ISOPROPYL MYRISTATE 2.23 mg in 1 g LIGHT MINERAL OIL 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:41520-979-02 1 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/15/2013 Labeler - American Sales Company (809183973) Registrant - American Sales Company (809183973) Establishment Name Address ID/FEI Business Operations OraLabs 801824756 MANUFACTURE(41520-979), LABEL(41520-979)