HYLANDS NATURALS VANILLA SUNSCREEN LIP BALM SPF 15- broad spectrum spf 15 vanilla lip balm stick

Hylands Naturals Vanilla Sunscreen Lip Balm SPF 15 by

Drug Labeling and Warnings

Hylands Naturals Vanilla Sunscreen Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Hylands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients
Avobenzone    2.0%
Octinoxate       6.5%
Octisalate        5.0%
Octocrylene    1.5%

PURPOSE

Purpose

Avobenzone     Sunscreen
Octinoxate        Sunscreen
Octisalate         Sunscreen
Octocrylene      Sunscreen

INDICATIONS & USAGE

Uses Helps prevent sunburn

WARNINGS

Warnings
For external use only Do not use on damaged or broken
skin. Stop use and ask a doctor if rash occurs. When
using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help
or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions Apply liberally 15 minutes before sun exposure Use
a water resistant sunscreen if swimming or sweating Reapply at least
every 2 hours Children under 6 months of age: 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.

INACTIVE INGREDIENT

Inactive Ingredients: Sunflower Oil*, Beeswax, Olive Oil*, Flavor,
Tocopherol,Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil,
Sunflower Seed Oil Glycerides, Canola Oil.   *Organic

OTHER SAFETY INFORMATION

Other Information:

Protect this product from excessive heat and direct sun.

Principal Display Package

Hyland's   SPF 15

NATURALS™

VANILLA SUNSCREEN LIP BALM

Manufactured for Hyland's Inc., P.O. Box 61067, Los ngeles, CA 90061   REV001 |  L391726

SAFETY SEAL

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INGREDIENTS AND APPEARANCE

HYLANDS NATURALS VANILLA SUNSCREEN LIP BALM SPF 15 
broad spectrum spf 15 vanilla lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
WHITE WAX (UNII: 7G1J5DA97F)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
CANOLA OIL (UNII: 331KBJ17RK)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL MONO/DIGLYCERIDES (UNII: HS7EB0C1ZH)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4123-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	10/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/18/2022

Labeler - Hylands (008316655)