ALBA BOTANICA HW SUNSCREEN GREEN TEA SPF45- avobenzone,homosalate, octocrylene,octyl salicylate 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.

----------

Alba Botanica Hawaiian Sunscreen Green Tea SPF 45

Active Ingredient

Avobenzone - 3.0%

Homosalate - 10.0%

Octocrylene - 10.0%

Ethylhexyl Salicylate - 5.0%

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.

Sunscreen

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.

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

Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, , Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1),Citrus Aurantium Dulcis ((Orange) Peel Oil, Lavandula Angustifolia (Lavender) Extract (1), Ginkgo Biloba Leaf Extract, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Triethyl Citrate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient

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.

tube label 6oz

ALBA BOTANICA HW SUNSCREEN GREEN TEA SPF45 
avobenzone,homosalate, octocrylene,octyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GINKGO (UNII: 19FUJ2C58T)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ORANGE OIL (UNII: AKN3KSD11B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2011-6170 g in 1 TUBE; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/26/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-2011)

Revised: 2/2021
Document Id: baa07d37-d55e-712e-e053-2a95a90a7ed7
Set id: 6288a339-f849-0ecc-e053-2a91aa0a0ad3
Version: 3
Effective Time: 20210205
 
The Hain Celestial Group, Inc.