AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50- avobenzone, 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.

----------

AL0043800 Alba Botanica Sheer Shield Sunscreen FF SPF50

Active Ingredient

Avobenzone - 3.0

Octocrylene -10.0

Octyl Salicylate - 5.0

Homosalate - 10.0

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. Children under 6 months: ask a doctor.

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

(1) Certified Organic 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.

AL00438 Label

AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50 
avobenzone, octocrylene, octyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-3438
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GINKGO (UNII: 19FUJ2C58T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-3438-185 g in 1 TUBE; Type 0: Not a Combination Product12/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/13/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (081512382)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-3438)

Revised: 4/2021
Document Id: bfc899d1-84ad-abdd-e053-2995a90a017a
Set id: 60f34ee1-2723-742d-e053-2a91aa0a9ab5
Version: 6
Effective Time: 20210412
 
The Hain Celestial Group, Inc.