you-v spf-30 broad spectrum sunscreen lotion

you-v spf-30 broad spectrum sunscreen lotion
SPL v3
SPL
SPL Set ID 290cd617-aa90-4f10-8a1d-d8954b927004
Route
topical
Published
Effective Date 2021-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (60 mg) zinc cation (35 mg)
Inactive Ingredients
aloe vera leaf aluminum hydroxide water ascorbyl palmitate yellow wax butyloctyl salicylate medium-chain triglycerides papaya cetearyl olivate cetyl alcohol coconut oil dimethicone ethyl vanillin ethylhexylglycerin glyceryl monostearate helianthus annuus flowering top linoleic acid green olive phenoxyethanol polysorbate 20 raspberry sodium hydroxide sorbitan olivate stearyl alcohol .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-07-22

Purpose

Sunscreen

Description

Titanium Dioxide 6.00% Zinc Oxide 3.50%


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 6.00% Zinc Oxide 3.50%

Questions?

Visit: youvsunscreen.com Distributed by: YouV LLC,

Uses:
  • Helps prevent sunburn. 
  • Higher SPF gives more sunburn protection.
  • If used as directed with other sun protection measures (see ), Decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Warnings:

not intended for ingestion. For external use only.

shine light directly into eyes. Do not

Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask doctor
  • Reapply at least every 2 hours.
  • Reapply as needed or after towel drying, swimming, or sweating.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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: Sun Protection Measures:

  • Limit time in the sun, especially between 10am and 2pm.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Do Not Use 
  • on damaged or broken skin. 
Package Labeling:

Active Ingredients

Titanium Dioxide 6.00%

Zinc Oxide 3.50%

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

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Hydroxide, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beeswax, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carica Papaya Fruit Extract, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethyl Vanillin, Ethylhexylglycerin, Fluorescent Brightener 230, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Laminaria (Algae) Extract, Linoleic Acid, Norbornanediamine/ Resorcinol Diglycidyl Ether Crosspolymer, Olea Europaea (Olive) Oil, Phenoxyethanol, Polysorbate-20, Rubus Idaeus (Raspberry) Extract, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

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.


Structured Label Content

Purpose

Sunscreen

Questions?

Visit: youvsunscreen.com Distributed by: YouV LLC,

Uses:
  • Helps prevent sunburn. 
  • Higher SPF gives more sunburn protection.
  • If used as directed with other sun protection measures (see ), Decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Warnings:

not intended for ingestion. For external use only.

shine light directly into eyes. Do not

Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask doctor
  • Reapply at least every 2 hours.
  • Reapply as needed or after towel drying, swimming, or sweating.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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: Sun Protection Measures:

  • Limit time in the sun, especially between 10am and 2pm.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Do Not Use  (Do not use )
  • on damaged or broken skin. 
Package Labeling:

Active Ingredients (Active ingredients)

Titanium Dioxide 6.00%

Zinc Oxide 3.50%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Other Ingredients: (Other ingredients:)

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Hydroxide, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beeswax, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carica Papaya Fruit Extract, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethyl Vanillin, Ethylhexylglycerin, Fluorescent Brightener 230, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Laminaria (Algae) Extract, Linoleic Acid, Norbornanediamine/ Resorcinol Diglycidyl Ether Crosspolymer, Olea Europaea (Olive) Oil, Phenoxyethanol, Polysorbate-20, Rubus Idaeus (Raspberry) Extract, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

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 or irritation develops and lasts.
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.


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