ALBA BOTANICA PURE LAVENDER SUNSCREEN SPF45- avobenzone, homosalate, octocrylene, octyl salicylate lotion

Alba Botanica Pure Lavender Sunscreen SPF45 by

Drug Labeling and Warnings

Alba Botanica Pure Lavender Sunscreen SPF45 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

Active Ingredient

Avobenzone - 3.0%

Homosalate - 10.0%

Octocrylene - 10.0%

Ethylhexyl Salicylate - 5.0%

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.

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, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Myrohylon Pereairae (Balsam Pery) oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Extract (1), Echinacea Angustifolia Extract (1), Ginkgo Biloba Leaf Extract, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf 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 PURE LAVENDER SUNSCREEN SPF45 
avobenzone, homosalate, octocrylene, octyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2093
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
XANTHAN GUM (UNII: TTV12P4NEE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GINKGO (UNII: 19FUJ2C58T)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ORANGE OIL (UNII: AKN3KSD11B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAVANDIN OIL (UNII: 9RES347CKG)
ROSEMARY OIL (UNII: 8LGU7VM393)
ASIAN GINSENG (UNII: CUQ3A77YXI)
BALSAM PERU OIL (UNII: DIK0395679)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2093-6	170 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/05/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		117115556	manufacture(61995-2093)