Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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WINCO MOISTURE SPF 15 LIP BALM- oxybenzone, octinoxate, petrolatum stick 
Winco

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

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (40.7%)

Purpose

Sunscreen, 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

Do not use on broken or damaged skin

Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.

When using this product keep out of eyes. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure. Reapply as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Ozokerite, Mineral Oil, Isocetyl Stearate, Microcrystalline Wax, Isopropyl Lanolate, Lanolin, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadenis Leaf Extract, Paraffin, Cetyl Alcohol, Tocerpheryl Linoleate, Flavor, Methylparaben, Propylparaben.

Package/Label Principal Display Panel

Winco SPF 15 Moisturizer Lip Balm Twin Pack
WINCO MOISTURE SPF 15 LIP BALM 
oxybenzone, octinoxate, petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67091-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.5 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM40.7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CERESIN (UNII: Q1LS2UJO3A) 17.13 mg  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP) 16.75 mg  in 1 g
ISOCETYL STEARATE (UNII: 3RJ7186O9W) 3.50 mg  in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H) 1 mg  in 1 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .60 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67091-250-301 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2015
Labeler - Winco (056098817)
Registrant - OraLabs (801824756)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(67091-250) , LABEL(67091-250)

Revised: 1/2015
 
Winco


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