SUNPLUS LIP LIFE- sunscreen stick

SUNPLUS LIP LIFE by

Drug Labeling and Warnings

SUNPLUS LIP LIFE by is a Otc medication manufactured, distributed, or labeled by I. Shay Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octocrylene 3%

Homosalate2%

Octisalate 2%

Avobenzone 2%

PURPOSE

Sunscreen protection

KEEP OUT OF REACH OF CHILDREN

WARNING: Keep out of reach of children.

INDICATIONS & USAGE

Helps prevent sunburn

Higher SFP gives more sunburn protection

Retains SPF after 40 minutes of swimming or sweating

If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the Sun.

INACTIVE INGREDIENT

Coconut oil, Caprylic, BehenylBehenate, Sunflower oil, Carnauba Wax, Candelilla Wax, Flavor, Glycerin, Safflower oil, Stevia, PolyhydroxystearicAcid, Organic Raspberry oil, Organic Jojoba oil, Organic Evening primrose oil, Organic Aloe vera oil, Lanolin acid, Tocopherol Acetate.

WARNINGS

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 or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including limit time in the sun, especially from 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNPLUS LIP LIFE 
sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65112-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.03 g  in 4.2 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.02 g  in 4.2 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.02 g  in 4.2 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.02 g  in 4.2 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65112-303-02	1 in 1 BOX	06/01/2024
1	NDC: 65112-303-01	4.2 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2024

Labeler - I. Shay Cosmetics (151582384)