Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Zinc Oxide - 17.0%
OTC - PURPOSE SECTION
Sunscreen
AL0043700 Alba Botanica Baby Mineral Sunscreen SPF50
- Manufacturer
- 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 23:37:52
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.
Warnings
WARNINGS SECTION
For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor.
Other Label Information
INACTIVE INGREDIENT SECTION
Water, Caprylic Capric Triglyceride, Coconut Alkanes, Mica, Glycerin, Polyglyceryl-2 Sesquioleate, Polyglyceryl-3 Ricinoleate, Glyceryl Isostearate, Aloe Barbadensis Leaf Juice(1), Butyrospermum Parkii (Shea) Butter,Citrus Aurantium Dulcis (Orange) Peel Oil, Copernica Cerifera (Carnauba) Wax, Juniperus Virginiana Oil, Camilla Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Brassica Alcohol, Coco-Caprylate/Caprate, Sodium Chloride, Alcohol (1), Polyhydroxystearic Acid,Tocopheryl Acetate, Biosaccharide Gum-1,C10-18 Triglycerides, Cetearyl Olivate, Glyceryl Caprylate, Potassium Hydroxide, Quartz, Sodium Anisate, Sorbitan Olivate, Ethylhexylglycerin. (1) Certified Organicf Ingredient
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61995-2437-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-51e9-a910-e053-dadaa90a0b85 | Alba Botanica Baby Mineral Sunscreen SPF 50 |
| 61995-2437-4 | 2021-02-05 | C162847 | 48780-1 | ba0f9c33-51e9-a910-e053-dadaa90a0b85 | Alba Botanica Baby Mineral Sunscreen SPF 50 |
| 61995-2437-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-51e9-a910-e053-dadaa90a0b85 | Alba Botanica Baby Mineral Sunscreen SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61995-2437-4 | AL0043700 Alba Botanica Baby Mineral Sunscreen SPF50 | 113 g in 1 TUBE | LOTION | 113 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61995-2437 | AL0043700 ALBA BOTANICA BABY MINERAL SUNSCREEN SPF50 (ZINC OXIDE) LOTION [THE HAIN CELESTIAL GROUP, INC.] | 3 | Legacy NDC, 1 package rows | 20210207_60cda526-4b44-00a3-e053-2a91aa0abac0.zip |
Products#
- AL0043700 Alba Botanica Baby Mineral Sunscreen SPF50
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61995-2437 | 61995-2437-4 |
Ingredients#
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Zinc Oxide - 17.0%
DOSAGE & ADMINISTRATION SECTION
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor.
OTC - PURPOSE SECTION
Sunscreen
WARNINGS SECTION
For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. 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 Poison Center right away.
INACTIVE INGREDIENT SECTION
Water, Caprylic Capric Triglyceride, Coconut Alkanes, Mica, Glycerin, Polyglyceryl-2 Sesquioleate, Polyglyceryl-3 Ricinoleate, Glyceryl Isostearate, Aloe Barbadensis Leaf Juice(1), Butyrospermum Parkii (Shea) Butter,Citrus Aurantium Dulcis (Orange) Peel Oil, Copernica Cerifera (Carnauba) Wax, Juniperus Virginiana Oil, Camilla Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Brassica Alcohol, Coco-Caprylate/Caprate, Sodium Chloride, Alcohol (1), Polyhydroxystearic Acid,Tocopheryl Acetate, Biosaccharide Gum-1,C10-18 Triglycerides, Cetearyl Olivate, Glyceryl Caprylate, Potassium Hydroxide, Quartz, Sodium Anisate, Sorbitan Olivate, Ethylhexylglycerin. (1) Certified Organicf Ingredient
INDICATIONS & USAGE SECTION
Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.