AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50- avobenzone, octocrylene, octyl salicylate lotion

AL0043800 Alba Botanica Sheer Shield Sunscreen FF SPF50 by

Drug Labeling and Warnings

AL0043800 Alba Botanica Sheer Shield Sunscreen FF SPF50 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%

Octocrylene -10.0%

Octyl 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. Children under 6 months: 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(1), Coco-Caprylate/Caprate, Water, Stearyl/Octyldodecyl/Citrate Crosspolymer, Glycerin, Glyceryl Stearate SE, Shea Butter Ethyl Esters, C14-22 Alcohols, Mica, Polyglyceryl-10 Pentastearate, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Argania Spinosa Kernel Oil (1), Bambusa Vulgaris Stem Extract, Simmondsia Chinensis (Jojoba) Seed Oil (1), Cocos Nucifera (Coconut) Fruit Juice, Cocos Nucifera (Coconut) Fruit Juice, Rosa Centifolia Flower Extract, Sodium Stearoyl Lactylate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Behenyl Alcohol, C12-20 Alkyl Glucoside, Biosaccharide Gum-1, Citric Acid, Glyceryl Caprylate, Potassium Hydroxide, Quartz, Sodium Anisate,Sodium Levulinate, Ethylhexylglycerin,

(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

AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50 
avobenzone, octocrylene, octyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2438
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
MICA (UNII: V8A1AW0880)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ARGAN OIL (UNII: 4V59G5UW9X)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2438-3	85 g in 1 TUBE; Type 0: Not a Combination Product	12/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/13/2017

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(61995-2438)