Hawaiian Tropic Silk Hydration Sunscreen Broad Spectrum SPF 30 by Edgewell Personal Care Brands, LLC

Hawaiian Tropic Silk Hydration Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Hawaiian Tropic Silk Hydration Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone,homosalate,octisalate,octocrylene lotion 
Edgewell Personal Care Brands, LLC

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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.

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, C12-15 Alkyl Benzoate, Diisopropyl Adipate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Acrylates/C12-22Alkyl Methacrylate Copolymer, Phenoxyethanol, Isohexadecane, Caprylyl Glycol, 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 Oxides

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*

30

BROAD SPECTRUM

SPF 30

12

HOUR

Moisturization**

with hydrating ribbons

UVA & UVB protection

6 FL. OZ. (177mL)

HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-551
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-551-54	170 g in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2020	02/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/23/2020	02/28/2022

Labeler - Edgewell Personal Care Brands, LLC (151179769)

Revised: 12/2023

Document Id: 0bb6357b-befb-eda2-e063-6394a90a1676

34390-5

Set id: b1cc98e5-ab2c-6af1-e053-2a95a90a50a2

Version: 4

Effective Time: 20231204