ALBA BOTANICA HAWAIIAN SPF 50 COCONUT- avobenzone, homosalate, octisalate, octocrylene spray

Alba Botanica Hawaiian SPF 50 Coconut by

Drug Labeling and Warnings

Alba Botanica Hawaiian SPF 50 Coconut by is a Otc medication manufactured, distributed, or labeled by Hain Celestial Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.9%

Homosalate 14.7%

Octisalate 4.9%

Octocrylene 7.6%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

DOSAGE & ADMINISTRATION

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. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other protective measures including:

• limit time in the sun, especially from 10am to 2pm
• and wear long-sleeved shirts, pants, hats and sunglasses.

WARNINGS

For external use only. Do not use on broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Alcohol Denat., Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Fragrance (Parfum), Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Diisopropyl Adipate, Ginkgo Biloba Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Panax Quinquefolius Root Extract, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Coumarin, Limonene, Linalool.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA BOTANICA HAWAIIAN SPF 50 COCONUT 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0389
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	14.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
AMERICAN GINSENG (UNII: 8W75VCV53Q)
AVOCADO OIL (UNII: 6VNO72PFC1)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHAMOMILE (UNII: FGL3685T2X)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GINKGO (UNII: 19FUJ2C58T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0389-1	148 mL in 1 CAN; Type 0: Not a Combination Product	10/01/2022
2	NDC: 61995-0389-2	177 mL in 1 CAN; Type 0: Not a Combination Product	10/01/2022
3	NDC: 61995-0389-3	237 mL in 1 CAN; Type 0: Not a Combination Product	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2022

Labeler - Hain Celestial Group, Inc (117115556)