HAWAIIAN TROPIC ANTIOXIDANT SUNSCREEN SPF 30 BROAD SPECTRUM- avobenzone,homosalate,octocrylene lotion

Hawaiian Tropic AntiOxidant Sunscreen SPF 30 Broad Spectrum by

Drug Labeling and Warnings

Hawaiian Tropic AntiOxidant Sunscreen SPF 30 Broad Spectrum 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 2.2%, Homosalate 7.0%, Octocrylene 4.2%

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.

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 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

Inactive Ingredients

Water, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco-Glucoside, Chlorphenesin, Fragrance, Xanthan Gum, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Psidium Guajava Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate

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(R)

AntiOxidant+

SUNSCREEN LOTION

Helps prevent skin damage

& skin aging from the sun

30

SPF 30 BROAD SPECTRUM

UVA & UVB PROTECTION

Reef Friendly*

with green tea extract

6 FL. OZ. (177 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC ANTIOXIDANT SUNSCREEN SPF 30 BROAD SPECTRUM 
avobenzone,homosalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.25 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GUAVA (UNII: 74O70D6VG0)
CHLORPHENESIN (UNII: I670DAL4SZ)
PAPAYA (UNII: KU94FIY6JB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANGO (UNII: I629I3NR86)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GLYCERIN (UNII: PDC6A3C0OX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
WATER (UNII: 059QF0KO0R)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PANTHENOL (UNII: WV9CM0O67Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCO GLUCOSIDE (UNII: ICS790225B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-362-24	170 g in 1 TUBE; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/27/2020

Labeler - Edgewell Personal Care Brands LLC (151179769)