ALBA BOTANICA SPF 50 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion

Alba Botanica SPF 50 Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

DOSAGE & ADMINISTRATION

● Apply liberally 15 minutes before sun exposure ● Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● 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 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

● wear long-sleeved shirts, pants, hats, and sunglasses

PURPOSE

Sunscreen

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.

INACTIVE INGREDIENT

Water (Aqua), Butyloctyl Salicylate, Dodecane, VP/Hexadecene Copolymer, Polyglyceryl-10 Pentastearate, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Glyceryl Oleate Citrate, Behenyl Alcohol, Phenoxyethanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice (1), Tocopheryl Acetate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Decane, Dimethylhydroxy Furanone, Nonanal, Nonane, Potassium Hydroxide, Sodium Phytate, Sodium Stearoyl Lactylate, Solanum Tuberosum (Potato) Starch, Sorbitan Olivate, Terpinel Acetate, Vanillin, Alcohol (1), Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate, Limonene

(1) Certified Organic Ingredient

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA BOTANICA SPF 50 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VANILLIN (UNII: CHI530446X)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ALCOHOL (UNII: 3K9958V90M)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NONANAL (UNII: 2L2WBY9K6T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL OLEATE (UNII: 4PC054V79P)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ORANGE PEEL (UNII: TI9T76XD44)
.ALPHA.-TERPINYL ACETATE, (+)- (UNII: T3M2S9HES8)
DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)
STARCH, POTATO (UNII: 8I089SAH3T)
C9-11 ALKANE/CYCLOALKANE (UNII: 3EZ541F5MW)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2029-1	59 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2019
2	NDC: 61995-2029-2	89 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2019
3	NDC: 61995-2029-3	113 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/19/2019

Labeler - The Hain Celestial Group, Inc (117115556)

Registrant - The Hain Celestial Group, Inc (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
Hain-Celestial Canada, ULC		201360821	manufacture(61995-2029)