ALBA BOTANICA SHEER MINERAL SPF 50- zinc oxide, titanium dioxide aerosol

Alba Botanica Sheer Mineral SPF 50 by

Drug Labeling and Warnings

Alba Botanica Sheer Mineral SPF 50 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

Zinc Oxide 14.7% (w/w)

Titanium Dioxide 4.3% (w/w)

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours. Children under 6 months of age: 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 (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydrobietate, Cetearyl Alcohol, Propanediol, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice

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

ALBA BOTANICA SHEER MINERAL SPF 50 
zinc oxide, titanium dioxide aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-3032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
COCO GLUCOSIDE (UNII: ICS790225B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPANEDIOL (UNII: 5965N8W85T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BENTONITE (UNII: A3N5ZCN45C)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-3032-1	148 g in 1 CAN; Type 0: Not a Combination Product	01/01/2022
2	NDC: 61995-3032-2	177 g in 1 CAN; Type 0: Not a Combination Product	01/01/2022
3	NDC: 61995-3032-3	237 g in 1 CAN; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2022

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (081512382)

Establishment
Name	Address	ID/FEI	Business Operations
Hain-Celestial Canada, ULC		201360821	manufacture(61995-3032)