HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30- avobenzone,octisalate,octocrylene stick

Hawaiian Tropic Lip Balm Sunscreen SPF 30 by

Drug Labeling and Warnings

Hawaiian Tropic Lip Balm Sunscreen 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]

Active Ingredients

Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen

Uses

helps prevent sunburn.

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 reapply after eating or drinking Children under 6 months: Ask a doctor. 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 ingredient

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, Flavor, PEG-8, Oryza Sativa (Rice) Bran Wax, Sodium Saccharin, Tocopheryl Acetate.

Other Information

protect this product from excessive heat and direct sun.

Questions / Comments

1-800-NO UV RAY

Principal Display Panel

TROPICAL flavor
SPF
30
HAWAIIAN TROPIC(R)
LIP BALM
Sunscreen Stick
Water Resistant (80 minutes)
OXYBENZONE &
OCTINOXATE FREE
MOISTURIZES
FOR 12 HOURS
(R)
0.14 OZ (4.25g)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30 
avobenzone,octisalate,octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
RICE BRAN (UNII: R60QEP13IC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-520-61	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2021

Labeler - Edgewell Personal Care Brands LLC (151179769)