AL0038400 ALBA BOTANICA FAST FIX SUN SPF30- octocrylene, octyl salicylate, zinc oxide stick

AL0038400 Alba Botanica Fast Fix Sun SPF30 by

Drug Labeling and Warnings

AL0038400 Alba Botanica Fast Fix Sun SPF30 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

Octyl Salicylate - 5.0%

Octocrylene - 10.0%

Zinc Ohide - 20.0%

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel dryingt 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

Caprylic/Capric Trigluceride, Cocos Nucifera (Cococnut) Oil (1), Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Glycerin, Hydrogenated Glyceryl Abietate, Glyceryl Behenate, Copernicia Cerifera (Carnauba) Wax, Cetearyl Alcohol, Raphanus Sativus (Radish) Seed Oil, Aloe Barbadensis Leaf Juice(1), Chamomilla Recutita (Matricaria) Flower Extract (1), Butyrospermum Parkii (Shea) Butter (1), Polysorbate 60, Tocopheryol, Theobroma Cacao (Cocoa) Seed Butter (1), Punica Granatum Seed Oil (1), Helianthus Annuus (Sunflower)Seed Oil, Natural Flavor, Citrus Aurantifolia (Lime) Oil,Euterpe Oleracea Fruit Extract (1), Panax Ginseng Root Extract.

(1) Certified Organicf Ingredient

INDICATIONS & USAGE

Helps prevents sunburns. If uses 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

AL0038400 ALBA BOTANICA FAST FIX SUN SPF30 
octocrylene, octyl salicylate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2384
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 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

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
CHAMOMILE (UNII: FGL3685T2X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
COCOA BUTTER (UNII: 512OYT1CRR)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERYL ABIETATE (UNII: 2F22LY70Q1)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
RAPHANUS SATIVUS VAR. SATIVUS SEED (UNII: A94I086Q5E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2384-1	1 in 1 CARTON	12/26/2017
1		14 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/26/2017

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(61995-2384)