ALBA BOTANICA KIDS MINERAL SUNSCREEN FF SPF30- zinc oxide, titanium dioxide cream 
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 Kids Mineral Sunscreen Lotion SPF 30

Titanium Dioxide 2.0%

Zinc Oxide 14.5%

Helps prevent sunburns. If used as directed with other sun protection measures decreases the risk of skin cancer and skin aging caused by the sun. Sun Protection Measures: Spending time on the sun increases your risk of skin cancer and skin aging. To decrease the risk regulary use Broad Spectrum Sunscreen with SPF 15 or higher and other protective measures including: limit time in sun, especially from 10am to 2 pm, and wear long-sleeved shirts, pants, hats ans sunglasses.

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.

Sunscreen

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

Water, Caprylic/Capric Triglyceride, Dimethicone, Ethyhexyl Palmitate, Sorbitan Sesquioleate, Glycerin, Glyceryl Isostearate, Butyrospermum PARKII (Shea Butter), Polyglyceryl-3 Ricinoleate, Helianthus Annuus (Sunflower) Seed Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitis Vinifera(Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Tocopheryl Acetate, Alcohol, Magnesium Sulfate, Polyxydroxystearic Acid, Silica, Sodium Chloride, Benzyl Alcohol, Phenoxyethanol.

AL00388 Label

ALBA BOTANICA KIDS MINERAL SUNSCREEN FF SPF30 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2088
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ALOE (UNII: V5VD430YW9)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHAMOMILE (UNII: FGL3685T2X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2088-4113 g in 1 TUBE; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (081512382)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-2088)

Revised: 4/2021
Document Id: bfc8ac7a-991d-362e-e053-2a95a90aa0d3
Set id: 639fd681-3b6e-1a55-e053-2991aa0ae7d3
Version: 5
Effective Time: 20210412
 
The Hain Celestial Group, Inc.