ALBA BOTANICA MAXIMUM SUNSCREEN SPF 70- avobenzone, homosalate, octisalate, octocrylene spray

Alba Botanica Maximum Sunscreen SPF 70 by

Drug Labeling and Warnings

Alba Botanica Maximum Sunscreen SPF 70 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 9.5%

INACTIVE INGREDIENT

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

PURPOSE

Sunscreen. Helps prevent sunburn

INDICATIONS & USAGE

● Hold container 4 to 6 inches/ from skin to apply ● Spray liberally/generously and spread evenly by hand 15 minutes before sun exposure. Do not spray directly onto face; spray on hands, then apply to face. Do not apply in windy conditions. Use in a well-ventilated area and avoid inhaling or exposing others to spray. ● reapply: ● at least every 2 hours ● after 40 minutes of swimming or sweating
● immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 am - 2 pm/ 11 a.m. – 3 p.m ■ wear long-sleeved shirts, pants, hats, and sunglasses. ● For use on children under 6 months of age, ask a doctor.

WARNINGS

For external use only.

Do not use on damaged or broken skin.

When using this product avoid contact with eyes.If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if rash occurs.

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

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA BOTANICA MAXIMUM SUNSCREEN SPF 70 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-3035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 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
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
AVOCADO OIL (UNII: 6VNO72PFC1)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
CAMELLIA OIL (UNII: T1PE06G0VE)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GINKGO (UNII: 19FUJ2C58T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-3035-1	148 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2021
2	NDC: 61995-3035-2	177 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

Labeler - Hain Celestial Group, Inc (117115556)