HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene lotion

Hawaiian Tropic by

Drug Labeling and Warnings

Hawaiian Tropic by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Purpose

Sunscreen

Uses

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

Warnings

For external use only.
May stain some fabrics and surfaces

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 rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

Other information

protect this product from excessive heat or direct sun

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Diisopropyl Adipate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Isohexadecane, Caprylyl Glycol, Benzyl Alcohol, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Fragrance, Polysorbate 60, Xanthan Gum, Coco-Glucoside, Disodium EDTA, Aminomethyl Propanol, Mica, Tocopheryl Acetate, Titanium Dioxide, Panthenol, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Sodium Ascorbyl Phosphate, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides

Questions or Comments?

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN TROPIC
SUNSCREEN LOTION
WEIGHTLESS
HYDRATION
12HR MOISTURIZATION

FACE
30

WON'T CLOG PORES
BROAD SPECTRUM SPF 30 UVA/UVB
1.7 FL. OZ (50 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-582
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
GUAVA (UNII: 74O70D6VG0)
MANGO (UNII: I629I3NR86)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
PAPAYA (UNII: KU94FIY6JB)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO GLUCOSIDE (UNII: ICS790225B)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOHEXADECANE (UNII: 918X1OUF1E)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-582-11	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/23/2020

Labeler - Edgewell Personal Care Brands, LLC (151179769)