CARE ONE CHERRY SPF 4 LIP BALM- petrolatum and padimate o stick 
American Sales Company

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.

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Drug Facts

Active ingredient

Padimate O, White 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 wind burned 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, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Camphor, Red 6 Lake (CI 15850), Methylparaben

Package/Label Principal Display Panel

Care One SPF 4 Lip Balm Card
CARE ONE CHERRY SPF 4 LIP BALM 
padimate o, petrolatum stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-978
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM44.0 mg  in 1 g
PADIMATE O (PADIMATE O) PADIMATE O1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL23.50 mg  in 1 g
MICROCRYSTALLINE WAX3.00 mg  in 1 g
LANOLIN1 mg  in 1 g
CERESIN17.50 mg  in 1 g
CARNAUBA WAX1 mg  in 1 g
ISOPROPYL MYRISTATE2.23 mg  in 1 g
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-978-021 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/15/2013
Labeler - American Sales Company (809183973)
Registrant - American Sales Company (809183973)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(41520-978), LABEL(41520-978)

Revised: 3/2013
Document Id: c8d6a93f-942b-4441-909c-0325bcbec4f5
Set id: c8d6a93f-942b-4441-909c-0325bcbec4f5
Version: 1
Effective Time: 20130311
 
American Sales Company