AL0043700 ALBA BOTANICA BABY MINERAL SUNSCREEN SPF50- zinc oxide 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 Baby Mineral Sunscreen SPF 50

Active Ingredient

Zinc Oxide - 17.0%

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, Caprylic Capric Triglyceride, Coconut Alkanes, Mica, Glycerin, Polyglyceryl-2 Sesquioleate, Polyglyceryl-3 Ricinoleate, Glyceryl Isostearate, Aloe Barbadensis Leaf Juice(1), Butyrospermum Parkii (Shea) Butter,Citrus Aurantium Dulcis (Orange) Peel Oil, Copernica Cerifera (Carnauba) Wax, Juniperus Virginiana Oil, Camilla Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Brassica Alcohol, Coco-Caprylate/Caprate, Sodium Chloride, Alcohol (1), Polyhydroxystearic Acid,Tocopheryl Acetate, Biosaccharide Gum-1,C10-18 Triglycerides, Cetearyl Olivate, Glyceryl Caprylate, Potassium Hydroxide, Quartz, Sodium Anisate, Sorbitan Olivate, Ethylhexylglycerin.

(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

AL0043700 ALBA BOTANICA BABY MINERAL SUNSCREEN SPF50 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2437
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
ORANGE OIL (UNII: AKN3KSD11B)  
POLYGLYCERYL-2 SESQUIISOSTEARATE (UNII: LA272Q68GQ)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CHAMOMILE (UNII: FGL3685T2X)  
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2437-4113 g in 1 TUBE; Type 0: Not a Combination Product12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/21/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-2437)

Revised: 2/2021
Document Id: ba9f9889-89ea-141a-e053-2995a90a9e9b
Set id: 60cda526-4b44-00a3-e053-2a91aa0abac0
Version: 3
Effective Time: 20210205
 
The Hain Celestial Group, Inc.