ALBA BOTANICA SHEER MINERAL SPF30- zinc oxide lotion

Alba Botanica Sheer Mineral SPF30 by

Drug Labeling and Warnings

Alba Botanica Sheer Mineral SPF30 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc., Hain-Celestial Canada, ULC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 24.1% (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), Caprylic/Capric Triglyceride, Ethylhexyl Olivate, Butyloctyl Salicylate, Isoamyl Laurate, Glyceryl Stearate SE, Niacinamide, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Tocopheryl Acetate, Glycerin, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Phytate, Squalane, Xanthan Gum, Alcohol (1), Ethylhexylglycerin, Phenoxyethanol

(1) Certified Organic 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

ALBA BOTANICA SHEER MINERAL SPF30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYL OLEATE (UNII: R34927QY59)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2033-1	59 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2022
2	NDC: 61995-2033-2	89 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2022
3	NDC: 61995-2033-3	113 g in 1 TUBE; 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(61995-2033)