Label: BABY MINERAL SPF 50- zinc oxide 17.0% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-0437-4 - Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated February 5, 2021
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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
BABY MINERAL SPF 50
zinc oxide 17.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0437 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0437-4 113 g in 1 TUBE; Type 0: Not a Combination Product 12/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/06/2019 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (014334364) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-0437)
