ALBA BOTANICA SPF 50 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion 
The Hain Celestial Group, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alba SPF 50 Sunscreen Lotion

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

● 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

Sunscreen

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.

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

Label

ALBA BOTANICA SPF 50 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
VANILLIN (UNII: CHI530446X)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
ALCOHOL (UNII: 3K9958V90M)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
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)  
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)  
NONANAL (UNII: 2L2WBY9K6T)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2029-159 g in 1 TUBE; Type 0: Not a Combination Product08/19/2019
2NDC:61995-2029-289 g in 1 TUBE; Type 0: Not a Combination Product08/19/2019
3NDC:61995-2029-3113 g in 1 TUBE; Type 0: Not a Combination Product08/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/19/2019
Labeler - The Hain Celestial Group, Inc (117115556)
Registrant - The Hain Celestial Group, Inc (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc081512382manufacture(61995-2029)

Revised: 2/2023
Document Id: f5436909-7219-3921-e053-2a95a90ac699
Set id: f5436909-7218-3921-e053-2a95a90ac699
Version: 1
Effective Time: 20230220
 
The Hain Celestial Group, Inc