WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 3N- zinc oxide cream

Well People Bio Tint SPF 30 Sunscreen 3N by

Drug Labeling and Warnings

Well People Bio Tint SPF 30 Sunscreen 3N 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 20%

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

Water (Aqua), Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Glycerin, Triethylhexanoin, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Disteardimonium Hectorite, Shea Butter Ethyl Esters, Polyhydoxystearic Acid, Lecithin, Isostearic Acid, Gluconolactone, Cocos Nucifera (Coconut) Oil/Cocos Nucifera Oil*, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil/ Helianthus Annuus Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil/ Simmondsia Chinensis Seed Oil*, Rubus Idaeus (Raspberry) Seed Oil/ Rubus Idaeus Seed Oil, Rosa Rubiginosa Seed Oil, Hippophase Rhamnoides (Sea Buckthorn) Oil/Hippophae Rhamnoides Oil, Crambe Abyssinica Seed Oil, Brassica Oleracea Italica (Broccoli) Seed Oil/ Brasica Oleracea Italica Oil, Aloe Barbadensis (Aloe) Leaf Juice/Aloe Barbadensis Leaf Juice, Maltodextrin, Potassium Sorbate, Glyceryl Caprylate, Sodium Benzoate, Isopropyl Titanium Triisostearate, Glyceryl Undecylenate, Calcium Gluconate, Phytic Acid MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) *Organic Ingredients

Questions or comments?

1-888-315-9814

Package Labeling:

INGREDIENTS AND APPEARANCE

WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 3N 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-480
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
RASPBERRY SEED OIL (UNII: 9S8867952A)
ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
BROCCOLI SEED OIL (UNII: SY01LVD4G4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
FYTIC ACID (UNII: 7IGF0S7R8I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-480-01	1 in 1 BOX	09/01/2021
1		35.5 mL 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)