Skip to Content

Zinka Passion Fruit SPF 15 Lip Balm

Dosage form: stick
Ingredients: OCTINOXATE 7.5mg in 1g, OXYBENZONE 3.5mg in 1g, PETROLATUM 42mg in 1g
Labeler: Zinka
NDC Code: 52993-111

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

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (42%)

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: 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

Ozokerite, Mineral Oil, PEG-8, Lanolin, Microcrystalline Wax, Flavor, Paraffin Wax, Copernicia Cerifera (Carnauba) Wax, Sucralose, Aloe Barbadenis Leaf Extract, Tocopherol, Methylparaben, Propylparaben.

Package/Label Principal Display Panel
ZINKA PASSION FRUIT SPF 15 LIP BALM 
oxybenzone, octinoxate, petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52993-111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3.5 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM42 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL13.00 mg  in 1 g
MICROCRYSTALLINE WAX3.00 mg  in 1 g
LANOLIN3 mg  in 1 g
CERESIN17 mg  in 1 g
PEG-8 STEARATE5 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorTROPICAL FRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52993-111-021 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/09/2014
Labeler - Zinka (153569595)
Registrant - Zinka (153569595)
Establishment
NameAddressID/FEIOperations
OraLabs801824756MANUFACTURE(52993-111), LABEL(52993-111)

 
Zinka

Medically reviewed on May 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide