OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 8%
Broad Spectrum SPF 30 Tropical Sunscreen
- Manufacturer
- Raining Rose, Inc
- Effective date
- 2024-05-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:47
Label at a glance#
ProductBroad Spectrum SPF 30 Tropical Sunscreen
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Sunscreen
INDICATIONS & USAGE SECTION
Helps prevent sunburn
WARNINGS SECTION
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
DOSAGE & ADMINISTRATION SECTION
Apply liberally 15 minutes before sun exposure
Reapply after 80 minutes of swimming or sweating.
Reapply immediately after towel drying.
Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor
Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sunprotection measures including:
limit time in the sun, especially from 10a.m.-2p.m.
wear long sleeved shirts, pants, hats and sunglasses.
OTHER SAFETY INFORMATION
Protect this product from excessive heat and direct sun.
INACTIVE INGREDIENT SECTION
Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Glycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Almond Oil, Tocopherol, Water, Xanthan Gum.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65692-0577-1 | Broad Spectrum SPF 30 Tropical Sunscreen | 30 mL in 1 BOTTLE, PLASTIC | LOTION | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65692-0577 | BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN LOTION [RAINING ROSE, INC] | 1 | Current NDC, 1 package rows | 20240522_18e7fc6b-b40a-f790-e063-6294a90ad0f4.zip |
Products#
Every source-derived product name is available through these pages.
- Broad Spectrum SPF 30 Tropical Sunscreen
- OCTISALATE
- GLYCERIN
- SOYBEAN OIL
- ALOE VERA LEAF
- POTASSIUM SORBATE
- TOCOPHEROL
- WATER
- AVOBENZONE
- OCTOCRYLENE
- CETEARYL GLUCOSIDE
- CETOSTEARYL ALCOHOL
- GRAPE SEED OIL
- SUNFLOWER OIL
- XANTHAN GUM
- PENTYLENE GLYCOL
- ALMOND OIL
- ANHYDROUS CITRIC ACID
- HOMOSALATE
- BENZYL ALCOHOL
- GLYCERYL STEARATE SE
- PROPANEDIOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65692-0577 | 65692-0577-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTISALATE | 4X49Y0596W | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| WATER | 059QF0KO0R | IACT |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| CETEARYL GLUCOSIDE | 09FUA47KNA | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| GRAPE SEED OIL | 930MLC8XGG | IACT |
| SUNFLOWER OIL | 3W1JG795YI | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| PENTYLENE GLYCOL | 50C1307PZG | IACT |
| ALMOND OIL | 66YXD4DKO9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| HOMOSALATE | V06SV4M95S | ACTIB |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| GLYCERYL STEARATE SE | FCZ5MH785I | IACT |
| PROPANEDIOL | 5965N8W85T | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Broad Spectrum SPF 30 Tropical Sunscreen | BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN | Raining Rose, Inc | 18e7fc6b-b40a-f790-e063-6294a90ad0f4 | 2024-05-20 | Warnings | 65692-0577-1 65692-0577 65692057701 18e7fc6b-b40b-f790-e063-6294a90ad0f4 18e7fc6b-b40a-f790-e063-6294a90ad0f4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.