Label: LIP BALM- octinoxate oxybenzone zinc oxide ointment
- NDC Code(s): 63550-114-01
- Packager: Kamins Dermatologics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated December 1, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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
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WARNINGS
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.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
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
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INGREDIENTS AND APPEARANCE
LIP BALM
octinoxate oxybenzone zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63550-114-01 15 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2004 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2004 Labeler - Kamins Dermatologics Inc. (254050784) Registrant - Odan Laboratories Ltd (208585604) Establishment Name Address ID/FEI Business Operations Odan Laboratories Ltd 208585604 manufacture(63550-114)
B. KAMINS