ATTITUDE - LIP BALM - SPF 15 - COCONUT- zinc oxide stick

Attitude - Lip Balm - SPF 15 - Coconut by

Drug Labeling and Warnings

Attitude - Lip Balm - SPF 15 - Coconut by is a Otc medication manufactured, distributed, or labeled by Attitude DBA 9055-7588 Québec Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Medicinal ingredient

Zinc oxide (10%)

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Do not use on broken skin.

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

Stop use and consult a doctor if rash occurs.

Directions

Adults and children older than 6 months.

• Apply generously 15 minutes before sun exposure.
• Reapply at least every 2 hours, after eating or drinking.
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses.
• Use a water resistant sunscreen if swimming or sweating.

Inactive or non-medicinal ingredients

Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecanol, CI 77491 (Iron Oxides), CI 77492 (Iron Oxides), CI 77742 (Manganese Violet), CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Stearoyl Glutamic Acid, Ethyl Acetate*, Ethyl Hexanoate*, Gamma-Nonalactone*, Gamma-Octalactone*, Vanillin*, *flavour (Aroma).

Other Information

Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.

QUESTIONS

Questions ? 1-855-509-7225

PRINCIPAL DISPLAY PANEL - 8.5 g Tube Carton

ATTITUDE

natural care

SPF 15

coconut

lip balm

universal shade

BROAD SPECTRUM SUNSCREEN SPF 15

UVA UVB + NON NANO

SUNLY Plastic Free Suncare

8.5 g / 0.3 oz.

NPN 80109103

Vegan

EWG Verified

Ocean Lovers

Dermatologically tested

INGREDIENTS AND APPEARANCE

ATTITUDE - LIP BALM - SPF 15 - COCONUT 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-985
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
OCTYLDODECANOL (UNII: 461N1O614Y)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CASTOR OIL (UNII: D5340Y2I9G)
ARGAN OIL (UNII: 4V59G5UW9X)
CANDELILLA WAX (UNII: WL0328HX19)
VANILLIN (UNII: CHI530446X)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
ETHYL CAPROATE (UNII: FLO6YR1SHT)
ETHYL ACETATE (UNII: 76845O8NMZ)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
MANGANESE VIOLET (UNII: 72M48QQV8Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61649-985-01	8.5 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/15/2024

Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
Attitude DBA 9055-7588 Québec Inc.		204307099	manufacture(61649-985) , label(61649-985) , pack(61649-985) , analysis(61649-985)