Your browser does not support JavaScript! CARE ONE ORIGINAL SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [AMERICAN SALES COMPANY]
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CARE ONE ORIGINAL SPF 4 LIP BALM (padimate o, petrolatum) stick
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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).

Package/Label Principal Display Panel

Care One SPF 4 Original Lip Balm Card
CARE ONE ORIGINAL SPF 4 LIP BALM 
padimate o, petrolatum stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-979
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
MICROCRYSTALLINE WAX3.00 mg  in 1 g
LANOLIN1 mg  in 1 g
CERESIN17.30 mg  in 1 g
CARNAUBA WAX1 mg  in 1 g
ISOPROPYL MYRISTATE2.23 mg  in 1 g
LIGHT MINERAL OIL27.50 mg  in 1 g
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-979-021 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(41520-979), LABEL(41520-979)

Revised: 3/2013
 
American Sales Company

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