WELL PEOPLE LIP BUTTER SPF 15 SUNSCREEN WINE- zinc oxide cream

Well People Lip Butter SPF 15 Sunscreen WINE by

Drug Labeling and Warnings

Well People Lip Butter SPF 15 Sunscreen WINE by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 10%

Purpose

Sunscreen

Use

• 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.

Warning

For external use only.

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

Directions

• Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
• Use water resistant sunscreen if swimming or sweating.
• 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 sun, especially from 10 a.m.-2 p.m., wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor. Sun Protection Measures:

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil/Ricinus Communis Seed Oil*, Octyldodecanol, Heliathus Annuus (Sunflower) Seed Oil/Helianthus Annuus Seed Oil*, Jojoba Esters, Simmondsia Chinensis (Jojoba) Seed Oil/Simmondsia Chinensis Seed Oil* Copernicia Cerifera (Camauba) Wax/Copernicia Cerifera Cera*, Oleic/Linoleic/Linolenic Polyglycerides, Euphorbia Cerifera (Candelilla) Wax/Euphorbia Cerifera Cera, Helianthus Annuus (Sunflower) Seed Wax/Helianthus Annuus Seed Wax, Rubus Idaeus (Raspberry) Seed Oil/Rubus Idaeus Seed Oil, Dibutyl Lauroyl Glutamide, Mica, Caprylic/Capric Triglyceride, Tocopherol, Prunus Amygdalus Dulcis (Sweet Almond) Oil/Prunus Amygdalus Dulcis Oil, Ethylhexylglycerin, Acacia Decurrens Flower Wax, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Lecithin, Isostearic Acid, Polyglycerin-3, Daucus Carota Sativa (Carrot) Seed Oil/Daucas Carota Sativa Seed Oil, Vanilla Planifolia Fruit Oil, Mentha Viridis (Spearmint) Leaf Oil/Mentha Viridis Leaf Oil, Camellia Sinensis (Green Tea) Leaf Extract/Camellia Sinensis Leaf Extract ,Limonene MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Red 7 Lake (CI 15850), Red 33 Lake (CI 17200) *Orgainc Ingredients

Questions or comments?

1-888-315-9814

Package Labeling:

INGREDIENTS AND APPEARANCE

WELL PEOPLE LIP BUTTER SPF 15 SUNSCREEN WINE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-491
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
RASPBERRY SEED OIL (UNII: 9S8867952A)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
ALMOND OIL (UNII: 66YXD4DKO9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CARROT SEED OIL (UNII: 595AO13F11)
CASTOR OIL (UNII: D5340Y2I9G)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
SPEARMINT OIL (UNII: C3M81465G5)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-491-01	1 in 1 BOX	09/01/2021
1		2.2 g in 1 BOTTLE; 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	09/01/2021

Labeler - e.l.f. Cosmetics, Inc (093902816)