AL0039006 ALBA SPORT SUNSCREEN FRAGRANCE FREE SPF45- homosalate, octinoxate, ethylhexyl salicylate, octocrylene, butul methoxydibenzoylmethane, titanium dioxide 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 Botanica Sport Sunscreen Fragrance Free SPF 45

Active Ingredient

Avobenzone - 3.0%

Homosalate - 10.0%

Octocrylene - 10.0%

Octyl 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), Lavandula Angustifolia (Lavender) Extract (1), Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Cetearyl Alcohol, Cetearyl Olivate, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, 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.

AL00390 Label

AL0039006 ALBA SPORT SUNSCREEN FRAGRANCE FREE SPF45 
homosalate, octinoxate, ethylhexyl salicylate, octocrylene, butul methoxydibenzoylmethane, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2090
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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)  
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)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GINKGO (UNII: 19FUJ2C58T)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2090-5113 g in 1 TUBE; Type 0: Not a Combination Product11/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/21/2016
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (081512382)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-2090)

Revised: 4/2021
Document Id: bfc8a727-0c8f-3152-e053-2995a90a28ba
Set id: 463e8172-8232-21b4-e054-00144ff88e88
Version: 5
Effective Time: 20210412
 
The Hain Celestial Group, Inc.