Sun Shades Lip Balm
- Product NDC
- 54473-226
- 11-digit product format
- 544730226
- Labeler code
- 54473
- Product ID
- 54473-226_4747c8ff-53eb-ef14-e063-6294a90ae4e0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- Melaleuca Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-02-01
- Substance
- AVOBENZONE; OCTINOXATE; OXYBENZONE
- Active strength
- .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sun Shades Lip Balm
- Brand name suffix
- Pina Colada
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | .1175 g/4.25g |
| OCTINOXATE | .282 g/4.25g |
| OXYBENZONE | .141 g/4.25g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, 4Y5P7MUD51, 95OOS7VE0Y |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54473-226-04 | Sun Shades Lip BalmPina Colada | 4.25 g in 1 TUBE | STICK | 4.25 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| AMMONIUM GLYCYRRHIZATE | INACTIVE INGREDIENT | 3VRD35U26C | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| CETYL ESTERS WAX | INACTIVE INGREDIENT | D072FFP9GU | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) | INACTIVE INGREDIENT | L5F16ZG4ZU | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54473-226 | SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240918_16d0d2d2-b9c4-4491-8d8a-815843d342e8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54473-226-04 | 54473022604 | 4.25 g in 1 TUBE (54473-226-04) | 4.25 g | 2018-01-01 | 0000-00-00 | No | No | Current |