Label: MEDICATED LIP BALM- dimethicone, oxybenzone, and 2-ethylhexyl dimethyl paba cream
- NDC Code(s): 74553-004-01
- Packager: Xtreme Tools International, 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 October 16, 2020
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- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Other information
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- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
MEDICATED LIP BALM
dimethicone, oxybenzone, and 2-ethylhexyl dimethyl paba creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74553-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 g in 100 g PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 6.6 g in 100 g Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74553-004-01 5 g in 1 JAR; Type 0: Not a Combination Product 10/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/14/2020 Labeler - Xtreme Tools International, Inc (125398904) Registrant - Xtreme Tools International, Inc (125398904) Establishment Name Address ID/FEI Business Operations Xtreme Tools International, Inc 125398904 manufacture(74553-004)