HAWAIIAN TROPIC SHEER TOUCH ULTRA RADIANCE SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone,homosalate,octo lotion

Hawaiian Tropic Sheer Touch Ultra Radiance Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Hawaiian Tropic Sheer Touch Ultra Radiance Sunscreen Broad Spectrum 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 2.2%, Homosalate 7.0%, Octocrylene 4.2%

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 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, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Mica, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, 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

BONUS

35% MORE

HAWAIIAN

Tropic®

Sheer Touch

Lotion Sunscreen

ULTRA RADIANCE

Reef Friendly*

30

UVA/UVB BROAD SPECTRUM

SPF 30

oil free

water resistant

(80 minutes)

10.8 FL. OZ. (319 mL)

HAWAIIAN

Tropic®

Sheer Touch

Lotion Sunscreen

ULTRA RADIANCE

Reef Friendly*

30

UVA/UVB BROAD SPECTRUM

SPF 30

oil free

water resistant

(80 minutes)

8 FL. OZ. (236 mL)

HAWAIIAN

Tropic®

Sheer Touch

Lotion Sunscreen

ULTRA RADIANCE

Reef Friendly*

30

UVA/UVB BROAD SPECTRUM

SPF 30

oil free

water resistant

(80 minutes)

2 FL. OZ. (59 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC SHEER TOUCH ULTRA RADIANCE SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone,homosalate,octo lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-491
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.25 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MANGO (UNII: I629I3NR86)
GLYCERIN (UNII: PDC6A3C0OX)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PAPAYA (UNII: KU94FIY6JB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R)
GUAVA (UNII: 74O70D6VG0)
MICA (UNII: V8A1AW0880)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
SHEA BUTTER (UNII: K49155WL9Y)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-491-11	56.7 g in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2019
2	NDC: 63354-491-16	227 g in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2019
3	NDC: 63354-491-17	306 g in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/18/2019

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc. (Ormond Beach		963501502	manufacture(63354-491)