HAWAIIAN SPF 15 ALOE SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion

Hawaiian SPF 15 Aloe Sunscreen by

Drug Labeling and Warnings

Hawaiian SPF 15 Aloe Sunscreen 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

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

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

● Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 am - 2 pm

● wear long-sleeved shirts, pants, hats, and sunglasses

PURPOSE

Sunscreen

WARNINGS

For external use only. Do not use on broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENT

Water (Aqua), Butyloctyl Salicylate, Dodecane, VP/Hexadecene Copolymer, Polyglyceryl-10 Pentastearate, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Glyceryl Oleate Citrate, Behenyl Alcohol, Phenoxyethanol, Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Ginkgo Biloba Leaf Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/ Stem Extract (1), Panax Ginseng Root Extract (1), Tocopheryl Acetate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Decane, Nonane, Potassium Hydroxide, Sodium Phytate, Sodium Stearoyl Lactylate, Solanum Tuberosum (Potato) Starch, Sorbitan Olivate, Alcohol (1), Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate

(1) Certified Organic Ingredient

INDICATIONS & USAGE

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAWAIIAN SPF 15 ALOE SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2027
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GINKGO BILOBA WHOLE (UNII: 660486U6OI)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL OLEATE (UNII: 4PC054V79P)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
STARCH, POTATO (UNII: 8I089SAH3T)
C9-11 ALKANE/CYCLOALKANE (UNII: 3EZ541F5MW)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2027-1	59 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2019
2	NDC: 61995-2027-2	89 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2019
3	NDC: 61995-2027-3	113 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/19/2019

Labeler - The Hain Celestial Group, Inc (117115556)

Registrant - The Hain Celestial Group, Inc (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
Hain-Celestial Canada, ULC		201360821	manufacture(61995-2027)