ALBA BOTANICA FACIAL MINERAL SUNSCREEN FF SPF20- zinc oxide, titanium dioxide lotion
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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Alba Botanica Facial Mineral Sunscreen FF SPF 20

Titanium Dioxide 2.0%

Zinc Oxide 8.0%

Helps prevent sunburns. If used as directed with other sun protection measures decreases the risk of skin cancer and skin aging caused by the sun. Sun Protection Measures: Spending time on the sun increases your risk of skin cancer and skin aging. To decrease the risk regulary use Broad Spectrum Sunscreen with SPF 15 or higher and other protective measures including: limit time in sun, especially from 10am to 2 pm, and wear long-sleeved shirts, pants, hats ans sunglasses.

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.

Sunscreen

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

Water, Caprylic/Capric Triglyceride, Dimethicone, Ethyhexyl Palmitate, Sorbitan Sesquioleate, Glycerin, Glyceryl Isostearate, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-3 Ricinoleate, Vitis Vinifera(Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Lavandula Angustifolia (Lavender) Flower Extract (1), Camellia Sinensis Leaf Extract (1), Echinacea Purpurea Extract (1), Myrtus Communis Leaf ExtractTocopheryl Acetate, Alcohol (1), Magnesium Sulfate, Polyxydroxystearic Acid, Silica, Sodium Chloride, Benzyl Alcohol, Phenoxyethanol, Sodium Benzoate.

tube label

ALBA BOTANICA FACIAL MINERAL SUNSCREEN FF SPF20
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61995-2087
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MYRTUS COMMUNIS LEAF (UNII: U20N87188F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ALOE (UNII: V5VD430YW9)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GRAPE SEED OIL (UNII: 930MLC8XGG)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ECHINACEA PURPUREA (UNII: QI7G114Y98)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61995-2087-4	113 g in 1 TUBE; Type 0: Not a Combination Product	08/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/03/2016	10/10/2019

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

Registrant - The Hain Celestial Group, Inc. (014334364)

Name	Address	ID/FEI	Business Operations
Establishment
The Hain Celestial Group, Inc.		081512382	manufacture(61995-2087)

Revised: 2/2021

Document Id: ba9f9889-89e2-141a-e053-2995a90a9e9b

Set id: 66c4a97a-f3d6-322b-e053-2991aa0a762f

Version: 3

Effective Time: 20210205

The Hain Celestial Group, Inc.