warnings
Warnings For external use only
Avobenzone, Homosalate, Octisalate
- Product NDC
- 75712-947
- 11-digit product format
- 757120947
- Labeler code
- 75712
- Product ID
- 75712-947_4c112ee8-7b3d-69da-e063-6294a90a906b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Old East Main Co.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-31
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE
- Active strength
- 30; 120; 50 mg/mL; mg/mL; mg/mL
- 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ce9a2139-c5c2-43e2-bd51-1f14ace594d9 | 2026-03-02 | Warnings, Adverse reactions |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reaction DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE, GOODLETTSVILLE, 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 |
|---|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 120 mg/mL |
| OCTISALATE | 50 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4X49Y0596W |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75712-947-34 | Avobenzone, Homosalate, Octisalate | 236 mL in 1 BOTTLE, PLASTIC | LOTION | 236 | 4 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75712-947-34 | 75712094734 | 236 mL in 1 BOTTLE, PLASTIC (75712-947-34) | 236 ml | 2023-08-31 | No | No | Current |