AL00378 Alba Cool Sport Sunscreen SPF50
- Manufacturer
- The Hain Celestial Group, Inc. | The Hain Celestial Group Inc.
- Effective date
- 2021-02-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:37:51
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Avobenzone 3.0%
Homosalate 15.0%
Octocrylene 8.0%
Octyl Salicylate 5.0%
OTC - PURPOSE SECTION
Sunscreen
INDICATIONS & USAGE SECTION
- Helps prevent sunburn. If uses as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.
WARNINGS SECTION
For external use only. Flammable.Do not use near heat, sparks or flames or while smoking. Do not puncture orincinerate. Contents under preassure .Do not store at temperature above 120°C. Do not use on damaged or broken skin. When using this product keep out of eye. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.
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.Hold 4 to 6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face. Use in well- ventilated areas. Reapply after 80 min of swimming or sweating, immediately after towel drying and at lease every two hrs. Children under 6 months: ask a doctor.
Skin protection measures:
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease a risk,regularly use a Sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially 10am- 2pm, wear long- sleeved shirts,pants, hats and sunglasses.
INACTIVE INGREDIENT SECTION
Alcohol, Acrylates/Octylacrylamide Copolymer, Persea Gratissima (Avocado) Oil, Diisopropyl Adipate, Citrus Limon (lemon) Oil, Aloe Barbadensis Leaf Juice, Amyris Balsamifera Bark Oil, Camellia Sinensis Leaf Extract, Chamomilla Recuitita (Matricaria) Flower Extract, Panax Ginseng Root Extract, Gingko Biloba Root Extract, Tocopheryl Acetate, Triethyl Citrate, Benzyl Salicylate, Citral, Citronellol, Hexyl Cinnamal, Hydroxycitronellol, Limonene.
OTC - QUESTIONS SECTION
Questions? Call 888-659-7730 or visit
www.albabotanica.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61995-2378-6 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-3d77-a910-e053-dadaa90a0b85 | Alba Cool Sport SPF 50 Sunscreen |
| 61995-2378-6 | 2021-02-05 | C162847 | 48780-1 | ba0f9c33-3d77-a910-e053-dadaa90a0b85 | Alba Cool Sport SPF 50 Sunscreen |
| 61995-2378-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3d77-a910-e053-dadaa90a0b85 | Alba Cool Sport SPF 50 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61995-2378-6 | AL00378 Alba Cool Sport Sunscreen SPF50 | 177 g in 1 BOTTLE, SPRAY | SPRAY | 177 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61995-2378 | AL00378 ALBA COOL SPORT SUNSCREEN SPF50 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE) SPRAY [THE HAIN CELESTIAL GROUP, INC.] | 3 | Legacy NDC, 1 package rows | 20210207_456017cd-3961-3263-e054-00144ff8d46c.zip |
Products#
Every source-derived product name is available through these pages.
- AL00378 Alba Cool Sport Sunscreen SPF50
- Avobenzone, Homosalate, Octocrylene, Octyl Salicylate
- CHAMOMILE
- TRIETHYL CITRATE
- ALOE VERA LEAF
- GREEN TEA LEAF
- GINKGO
- ASIAN GINSENG
- .ALPHA.-TOCOPHEROL ACETATE
- ALCOHOL
- DIISOPROPYL ADIPATE
- LIMONENE, (+)-
- OCTOCRYLENE
- OCTISALATE
- AVOBENZONE
- HOMOSALATE
- AMYRIS BALSAMIFERA OIL
- LEMON OIL
- AVOCADO OIL
- PEPPERMINT OIL
- MENTHYL LACTATE, (-)-
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61995-2378 | 61995-2378-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHAMOMILE | FGL3685T2X | IACT |
| TRIETHYL CITRATE | 8Z96QXD6UM | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| GREEN TEA LEAF | W2ZU1RY8B0 | IACT |
| GINKGO | 19FUJ2C58T | IACT |
| ASIAN GINSENG | CUQ3A77YXI | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| DIISOPROPYL ADIPATE | P7E6YFV72X | IACT |
| LIMONENE, (+)- | GFD7C86Q1W | IACT |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| HOMOSALATE | V06SV4M95S | ACTIB |
| AMYRIS BALSAMIFERA OIL | I1BJ961J2E | IACT |
| LEMON OIL | I9GRO824LL | IACT |
| AVOCADO OIL | 6VNO72PFC1 | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| MENTHYL LACTATE, (-)- | 2BF9E65L7I | 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 |
|---|---|---|---|---|---|---|
| baa04ed7-1af0-6df2-e053-2a95a90a89c0 | 456017cd-3961-3263-e054-00144ff8d46c | 2021-02-05 | Warnings | baa04ed7-1af0-6df2-e053-2a95a90a89c0 456017cd-3961-3263-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
