ALBA BOTANICA SENSITIVE MINERAL SUNSCREEN SPF 33- zinc oxide aerosol

Alba Botanica Sensitive Mineral Sunscreen SPF 33 by

Drug Labeling and Warnings

Alba Botanica Sensitive Mineral Sunscreen SPF 33 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 18.3% (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

Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco-Glucoside, Ethyl Macadamiate, Ginkgo Biloba Leaf Extract, Glycerin, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Methyl Dihydroabietate, Microcrystalline Cellulose, Propanediol, Shea Butter Ethyl Esters, Sodium Gluconate, Tocopherol, Water (Aqua)

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 SENSITIVE MINERAL SUNSCREEN SPF 33 
zinc oxide aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-3033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SODIUM GLUCONATE (UNII: R6Q3791S76)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PROPANEDIOL (UNII: 5965N8W85T)
COCO GLUCOSIDE (UNII: ICS790225B)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENTONITE (UNII: A3N5ZCN45C)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PEG-4 CAPRYLIC/CAPRIC GLYCERIDES (UNII: H45189YI2Q)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-3033-1	148 g in 1 CAN; Type 0: Not a Combination Product	01/01/2022
2	NDC: 61995-3033-2	177 g in 1 CAN; Type 0: Not a Combination Product	01/01/2022
3	NDC: 61995-3033-3	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
The Hain Celestial Group, Inc.		081512382	manufacture(61995-3033)