Active Ingredients

Avobenzone 1.0%, Octocrylene 2.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 rash occurs.

Keep out of reach of children

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

May stain

some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two hours • children under 6 months: Ask a doctor

Inactive ingredients

Water, Petrolatum, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Sodium Polyacrylate, Chlorphenesin, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Xanthan Gum, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Disodium EDTA, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract

Other information

• protect this product from excessive heat and direct sun

Questions or Comments?

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

Principal Display Panel

HAWAIIAN
Tropic®
SUNSCREEN LOTION
ISLAND TANNING
ENHANCE TAN & MOISTURIZE
COCOA BUTTER
CRUELTY FREE | VEGAN
SPF 4 UVB
WATER RESISTANT (80 MINUTES)
8 FL. OZ (236 mL)

Label

HAWAIIAN TROPIC ISLAND TANNING SUNSCREEN COCOA BUTTER SPF 4
avobenzone,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63354-771
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
GUAVA (UNII: 74O70D6VG0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PAPAYA (UNII: KU94FIY6JB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
CHLORPHENESIN (UNII: I670DAL4SZ)
MANGO (UNII: I629I3NR86)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63354-771-16	227 g in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2019
2	NDC:63354-771-17	306 g in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2019	10/26/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/13/2019

Labeler - Edgewell Personal Care Brands, LLC (151179769)