ALBA BOTANICA SHEER MINERAL SPF 50- zinc oxide, titanium dioxide aerosol 
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 Sheer Minieal SPF 50

Zinc Oxide 14.7% (w/w)

Titanium Dioxide 4.3% (w/w)

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.

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), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydrobietate, Cetearyl Alcohol, Propanediol, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice

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.

Label

ALBA BOTANICA SHEER MINERAL SPF 50 
zinc oxide, titanium dioxide aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-3032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPANEDIOL (UNII: 5965N8W85T)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
.BETA.-BISABOLOL (UNII: LP618AV2EA)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
COCONUT OIL (UNII: Q9L0O73W7L)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
BENTONITE (UNII: A3N5ZCN45C)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-3032-1148 g in 1 CAN; Type 0: Not a Combination Product01/01/2022
2NDC:61995-3032-2177 g in 1 CAN; Type 0: Not a Combination Product01/01/2022
3NDC:61995-3032-3237 g in 1 CAN; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2022
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (081512382)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-3032)

Revised: 6/2023
Document Id: fe07d8ed-f65c-237f-e053-6294a90a637b
Set id: fe07d84c-08c4-5868-e053-6294a90a0d05
Version: 1
Effective Time: 20230613
 
The Hain Celestial Group, Inc.