Pure Haven Body Spf-30

Pure Haven Body Spf-30
SPL v2
SPL
SPL Set ID 6f298fcd-8a97-8f66-e053-2991aa0adb10
Route
TOPICAL
Published
Effective Date 2018-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Cetostearyl Alcohol Cetearyl Glucoside Cetearyl Olivate Glycerin Glyceryl Monostearate Helianthus Annuus Flowering Top Leuconostoc/radish Root Ferment Filtrate Almond Sesame Oil Sorbitan Olivate Cocoa Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-01

Description

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Uses:
  • 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.
Do Not Use
  • on damaged or broken skin.
Directions:
  • Apply liberally 15-minutes before sun exposure.
  • Reapply:

- At least every two-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this riks, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, cansult a physician.









SUN PROTECTION MEASURES.

Active Ingredient

Titanium Dioxide (6.00%)

Zinc Oxide (6.00%)

Other Ingredients

Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tree) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita, Glycerin, Glyceryl Stearate, Heliathus Annuus (Sunflower) Oil, Leuconostoc/ Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

Package Labeling:

Other Information:
  • Protect this product from excessive heat and direct sunlight.
When Using This Product 

keep out of eyes. Rinse with water to remove.

Warnings: for External Use
  • For external use only.
Keep Out of Reach of Children.
  • If product is swallowed, get medical attention or contact poison control center immediately.
Stop Use and Consult Physician 
  • if irritation or rash develops.

Structured Label Content

Uses:
  • 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

Do Not Use (Do not use)
  • on damaged or broken skin.
Directions:
  • Apply liberally 15-minutes before sun exposure.
  • Reapply:

- At least every two-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this riks, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, cansult a physician.









SUN PROTECTION MEASURES.

Active Ingredient

Titanium Dioxide (6.00%)

Zinc Oxide (6.00%)

Other Ingredients (Other ingredients)

Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tree) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita, Glycerin, Glyceryl Stearate, Heliathus Annuus (Sunflower) Oil, Leuconostoc/ Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

Package Labeling:

Other Information:
  • Protect this product from excessive heat and direct sunlight.
When Using This Product  (When using this product )

keep out of eyes. Rinse with water to remove.

Warnings: for External Use (Warnings: For external use)
  • For external use only.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If product is swallowed, get medical attention or contact poison control center immediately.
Stop Use and Consult Physician  (Stop use and consult physician )
  • if irritation or rash develops.

Advanced Ingredient Data


Raw Label Data

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