BABY MINERAL SPF 50- zinc oxide 17.0% 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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AL00437 Baby Mineral SPF 50+

Active ingredients

Dose & Administration

Purpose

Warnings

Keep out of reach of children

Inactive ingredients

Indication & Use

PDP

BABY MINERAL SPF 50 
zinc oxide 17.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0437
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
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
O-ANISALDEHYDE (UNII: 7CP821WF2W)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
SHEA BUTTER (UNII: K49155WL9Y)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM ANISATE (UNII: F9WFJ28MV9)  
VANILLIN (UNII: CHI530446X)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
ALCOHOL (UNII: 3K9958V90M)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
GERANIOL (UNII: L837108USY)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
ORANGE OIL (UNII: AKN3KSD11B)  
CHAMOMILE (UNII: FGL3685T2X)  
BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-2 SESQUIOLEATE (UNII: RHP7Q83BVB)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MICA (UNII: V8A1AW0880)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0437-4113 g in 1 TUBE; Type 0: Not a Combination Product12/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/06/2019
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-0437)

Revised: 2/2021
Document Id: ba9f6ffe-e3c2-b48c-e053-2995a90a6928
Set id: 9974b40d-2596-2a0e-e053-2a95a90a9246
Version: 2
Effective Time: 20210205
 
The Hain Celestial Group, Inc.