HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone,homosalate,octisalate,octocrylene lotion

Hawaiian Tropic Silk Hydration Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Hawaiian Tropic Silk Hydration Sunscreen Broad Spectrum SPF 50 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 2.7%, Homosalate 8.0%, Octisalate 4.0%, Octocrylene 4.5%

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 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 value 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, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dissopropyl Adipate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Phenoxyethanol, Isohexadecane, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Fragrance, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, 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 Oxidea

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)

Silk

HYDRATION (R)

Lotion Sunscreen

WEIGHTLESS

Reef Friendly*

50
BROAD SPECTRUM

SPF 50

12

HOUR

Moisturization**

with hydrating ribbons

UVA & UVB protection

6 FL. OZ. (177mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GUAVA (UNII: 74O70D6VG0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MANGO (UNII: I629I3NR86)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
COCO GLUCOSIDE (UNII: ICS790225B)
PAPAYA (UNII: KU94FIY6JB)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
ISOHEXADECANE (UNII: 918X1OUF1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
MICA (UNII: V8A1AW0880)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
XANTHAN GUM (UNII: TTV12P4NEE)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-171-54	170 g in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/26/2020

Labeler - Edgewell Personal Care Brands, LLC (151179769)