HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN FACE BROAD SPECTRUM SPF 30- 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 2.0%, 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

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

Other information

protect this product from excessive heat or direct sun

Questions or Comments?

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

Principal Display Panel

HAWAIIAN TROPIC (R)

OIL-FREE SUNSCREEN LOTION

WEIGHTLESS

HYDRATION FACE

12HR MOISTURIZATION

30

CRUELTY FREE / DERM TESTED

BROAD SPECTRUM SPF 30 UVA/UVB

1.7 FL. OZ (50mL)

PDP Label

Back Labels

HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN FACE BROAD SPECTRUM SPF 30 
avobenzone,homosalate,octisalate,octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-581
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63354-581-1148.19 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/23/2020
Labeler - Edgewell Personal Care Brands, LLC (151179769)

Revised: 9/2023
Document Id: 053e273b-56f8-ee07-e063-6394a90abbaa
Set id: b1cf30c0-c41e-0982-e053-2a95a90a6f22
Version: 4
Effective Time: 20230913
 
Edgewell Personal Care Brands, LLC