HAWAIIAN TROPIC ANTIOXIDANT SUNSCREEN SPF 50 BROAD SPECTRUM- avobenzone,homosalate,octisalate,octocrylene lotion 
Edgewell Personal Care Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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

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 Ascorby Phosphate

Other information

• protect this product from excessive heat and direct sun

Questions or Comments?

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

Primary Display Panel

HAWAIIAN

Tropic (R)

AntiOxidant+

SUNSCREEN LOTION

Helps prevent skin damage

& skin aging from the sun

50

SPF 50 BROAD SPECTRUM

UVA & UVB PROTECTION

Reef Friendly*

with green tea extract

6 FL.OZ (177 mL)

63354-363-24

HAWAIIAN TROPIC ANTIOXIDANT SUNSCREEN SPF 50 BROAD SPECTRUM 
avobenzone,homosalate,octisalate,octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-363
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCO GLUCOSIDE (UNII: ICS790225B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
GUAVA (UNII: 74O70D6VG0)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PAPAYA (UNII: KU94FIY6JB)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
WATER (UNII: 059QF0KO0R)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MANGO (UNII: I629I3NR86)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63354-363-24170 g in 1 TUBE; Type 0: Not a Combination Product06/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/18/2020
Labeler - Edgewell Personal Care Brands LLC (151179769)

Revised: 7/2022
 
Edgewell Personal Care Brands LLC