LIP BALM- octinoxate oxybenzone zinc oxide ointment 
Kamins Dermatologics Inc.

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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CONSUMER LABELING

Active ingredients:


OCTINOXATE 7.5%


OXYBENZONE 5.0%


ZINC OXIDE 4.0%

Purpose: Sunscreen product

Keep out of the reach of children.


A soothing treatment balm that helps heal and protect lips from sun, wind and extreme tempera- tures. Repairs happed, sore lips with Bio-MapleTM compound and skin softening oils. Also helps prevent the breakout of lip sores with broad spectrum UVA/UVB sun screening agents. Creates a smoother palette for lipstick application by diminishing the appearance of lip lines and reducing the feathering of lip color. Use anytime for fuller, more luscious lips

Uses

helps prevent sunburn

higher SPF gives more sunburn protection

provides moderate protection against sunburn

Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.



Sun alert: limiting sun exposure, earing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.





Directions

Using the angled tube applicator, squeeze tube and apply directly to lips 15-30 minutes before sun exposure. Reapply as needed, especially after prolonged sun exposure, drinking or eating.

Children under 6 months of age: ask a doctor.




Inactive ingredients: Polybutene, ricinus communis (castor) seed oil, petrolatum, VP/hexadecene copolymer, cera alba (beeswax), cyclopentasiloxane/dimethicone crosspolymer, caprylic/capric triglyceride, squalane, copernicia cerifera (carnauba wax), paraffin, tocopheryl acetate, acer saccharum (maple isolate), flavour/aroma, benzyl benzoate.

B. KAMINS
LIP BALM SPF 20 box

Lip Balm Package Label BoxB. KAMINS
LIP BALM SPF 20
15 G / 0.5 oz
DIN 02248084

LIP BALM 
octinoxate oxybenzone zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
CASTOR OIL (UNII: D5340Y2I9G)  
PETROLATUM (UNII: 4T6H12BN9U)  
1-HEXADECENE (UNII: 97T015M2UX)  
WHITE WAX (UNII: 7G1J5DA97F)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRICAPRIN (UNII: O1PB8EU98M)  
TRICAPRYLIN (UNII: 6P92858988)  
SQUALANE (UNII: GW89575KF9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ACER SACCHARUM SAP (UNII: 75UOH57984)  
BENZYL BENZOATE (UNII: N863NB338G)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-114-0115 g in 1 TUBE; Type 0: Not a Combination Product02/01/2004
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2004
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Odan Laboratories Ltd (208585604)
Establishment
NameAddressID/FEIBusiness Operations
Odan Laboratories Ltd208585604manufacture(63550-114)

Revised: 12/2022
Document Id: eeca812d-b153-1e04-e053-2a95a90a274f
Set id: f2db718b-5691-45fc-9457-7ca54336e4bf
Version: 11
Effective Time: 20221201
 
Kamins Dermatologics Inc.