HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30- avobenzone,homosalate,octisalate,octocrylene liquid

HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30 by

Drug Labeling and Warnings

HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30 by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC, Playtex Manufacturing Inc. (Ormond Beach). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.7%, Homosalate 6.0%, Octisalate 4.5%,
Octocrylene 4.5%

Purpose

Sunscreen Agent

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 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 two 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, Silica,
Propylene Glycol, Cetyl Dimethicone,
Phenoxyethanol, Mica, Sodium
Polyacrylate, Acrylates/C12-22 Alkyl
Methacrylate Copolymer, Caprylyl
Glycol, Fragrance, Chlorphenesin,
Glycerin, Disodium EDTA, Aloe
Barbadensis Leaf Juice, Sodium
Hyaluronate, Hibiscus Sabdariffa
Flower Extract, Carica Papaya (Papaya)
Fruit Extract, Mangifera Indica (Mango)
Fruit Extract, Passiflora Incarnata Fruit
Extract, Plumeria Acutifolia Flower
Extract, Psidium Guajava Fruit Extract,
Titanium Dioxide.

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

OIL-FREE SUNSCREEN SERUM

SHEER TOUCH
FACE

LEAVES SKIN RADIANT
HYALURONIC ACID
30

CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 30 UVA/UVB

1.4 FL. OZ (41 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30 
avobenzone,homosalate,octisalate,octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-197
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
PAPAYA (UNII: KU94FIY6JB)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANGO (UNII: I629I3NR86)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-197-21	41 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2022	10/31/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2022	10/31/2026

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc. (Ormond Beach)		963501502	manufacture(63354-197)