Avobenzone, Homosalate, Octisalate
- Product NDC
- 75712-946
- 11-digit product format
- 757120946
- Labeler code
- 75712
- Product ID
- 75712-946_4c11298c-3097-5f19-e063-6294a90aa65b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Old East Main Co.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-24
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE
- Active strength
- 30; 150; 50 mg/g; mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings For external use only
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reaction DSP-TN-21091 DSP-MO-20087 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETSVILLE, TN 37072 100% Satisfaction Guaranteed! (888) 309-9030
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Avobenzone, Homosalate, Octisalate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/g |
| HOMOSALATE | 150 mg/g |
| OCTISALATE | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4X49Y0596W |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75712-946-14 | Avobenzone, Homosalate, Octisalate | 156 g in 1 CAN | SPRAY | 156 | | 6 |
| 75712-946-39 | Avobenzone, Homosalate, Octisalate | 312 g in 1 CAN | SPRAY | 312 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75712-946 | AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [OLD EAST MAIN CO.] | 3 | Current NDC, 2 package rows | 20240415_086dfda5-9fe7-46b4-9964-4977b86cfdd5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 75712-946-14 | 75712094614 | 156 g in 1 CAN (75712-946-14) | 156 g | 2023-08-24 | No | No | Current |
| 75712-946-39 | 75712094639 | 312 g in 1 CAN (75712-946-39) | 312 g | 2023-08-24 | No | No | Current |