Well People Bio Tint Spf 30 Sunscreen 1c

Well People Bio Tint Spf 30 Sunscreen 1c
SPL v5
SPL
SPL Set ID c8a82c8b-e308-15e9-e053-2995a90afa2a
Route
TOPICAL
Published
Effective Date 2021-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (200 mg)
Inactive Ingredients
Water Cocoyl Caprylocaprate Polyglyceryl-3 Pentaricinoleate Glycerin Triethylhexanoin Butyloctyl Salicylate Butylene Glycol Medium-chain Triglycerides Polyglyceryl-4 Isostearate Magnesium Sulfate, Unspecified Form Disteardimonium Hectorite Shea Butter Ethyl Esters Isostearic Acid Gluconolactone Coconut Oil Tocopherol Sunflower Oil Jojoba Oil Raspberry Seed Oil Rosa Rubiginosa Seed Oil Crambe Hispanica Subsp. Abyssinica Seed Oil Broccoli Seed Oil Aloe Vera Leaf Maltodextrin Potassium Sorbate Glyceryl Caprylate Sodium Benzoate Isopropyl Titanium Triisostearate Glyceryl 1-undecylenate Calcium Gluconate Fytic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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.

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:
Do Not Use

on damaged or broken skin.

Drug Facts

Active Ingredient

Zinc Oxide 20%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

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

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.


Structured Label Content

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.
Purpose

Sunscreen

Warning

For external use only.

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:
Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 20%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

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? (Questions or comments?)

1-888-315-9814

When Using This Product: (When using this product:)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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