ALBA GOOD AND HEALTHY MOISTURIZER SPF15- 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.

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Active Ingredient

Zinc Oxide 4.8%

Titanium Dioxide 3.7%

Cream.For sunscreen use apply liberall yafter cleansing and 15 minutes before sun exposure.Remove safety seal under cup prior to first use. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating

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,Glycerin, Isoamyl Laurate, Coconut Alkanes, Polyglyceryl-2 Sesquioleate, Polyglyceryl-3 Ricinoleate, Aloe Barbadensis Leaf Juice(1), Polyhydroxystearic Acid, Echinacea Purpurea Extract, Polygonum Aviculare Extract, Brassica Oleracea Acephala Leaf Extract, Elettaria Cardamomum Seed Extract, Ribes Nigrum (Blackcurrant) Leaf Extract, Rubus Idaeus (Raspberry) Leaf Extract, Spinacia Oleracea (Spinach) Leaf Extract, Garcinia Indica Seed Butter, Ascorbyl Glucoside, Biosaccharide Gum-1, Bisabolol, Retinyl Palmitate,Sucrose, Tapioca Starch,Lavandula Angusiofolia (Lavender) Oil, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Beta Vulgaris (Beet)Root Extract, Alumina, Calcium Ascorbate, Coco-Caprylate/Caprate ,Xanthophyl,Glyceryl Caprylate, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Stearic Acid, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Sodium Anisate, Sodium Lavulinate.

(1) Certified Organicf Ingredient

Helps prevents sunburns. If uses 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 labelcarton label

ALBA GOOD AND HEALTHY MOISTURIZER SPF15 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2789
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)  
RIBES NIGRUM LEAF (UNII: Z46FSZ2M25)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
CARDAMOM (UNII: 8BC4CUT4JL)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
LEVOMENOL (UNII: 24WE03BX2T)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SUCROSE (UNII: C151H8M554)  
LUTEIN (UNII: X72A60C9MT)  
BETA VULGARIS (UNII: 4G174V5051)  
CALCIUM ASCORBATE (UNII: 183E4W213W)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
SORBIC ACID (UNII: X045WJ989B)  
KALE (UNII: 0Y3L4J38H1)  
SODIUM ANISATE (UNII: F9WFJ28MV9)  
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2789-21 in 1 CARTON01/27/2014
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/27/2014
Labeler - The Hain Celestial Group, Inc. (858894996)
Registrant - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture(61995-2789)

Revised: 10/2014
Document Id: 06840628-9ec3-04f7-e054-00144ff88e88
Set id: 06840628-9ec2-04f7-e054-00144ff88e88
Version: 1
Effective Time: 20141029
 
The Hain Celestial Group, Inc.