AL0043700 ALBA BOTANICA BABY MINERAL SUNSCREEN SPF50- zinc oxide lotion

AL0043700 Alba Botanica Baby Mineral Sunscreen SPF50 by

Drug Labeling and Warnings

AL0043700 Alba Botanica Baby Mineral Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide - 17.0%

DOSAGE & ADMINISTRATION

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.

PURPOSE

Sunscreen

WARNINGS

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

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

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AL0043700 ALBA BOTANICA BABY MINERAL SUNSCREEN SPF50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2437
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2437-4	113 g in 1 TUBE; Type 0: Not a Combination Product	12/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/21/2017

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.		117115556	manufacture(61995-2437)