Sunscreen Lotion Broad Spectrum Spf 30

Sunscreen Lotion Broad Spectrum Spf 30
SPL v1
SPL
SPL Set ID 9c084eb9-91b0-49be-9830-19c8920d4b21
Route
TOPICAL
Published
Effective Date 2020-06-09
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 Carrot Ethylhexylglycerin Ethylhexyl Palmitate Glycerin Soybean Oil Helianthus Annuus Flowering Top Phenoxyethanol Almond Oil Sesame Oil Cocoa Tocopherol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-25

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.
Section 42229-5

Do not store in excessive heat or direct sunlight.

Warnings
  • For external use only.
Directions
  • Apply liberally 15-minutes before sun exposure.
  • Reapply: 
  • At least,every 2 hours.
  • Immediately after swimming, sweating or towel drying.
  • SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, 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, consult a physician.
Do Not Use
  • on damaged or broken skin.
Active Ingredient

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Package Labeling:

Inactive Ingredients
  • Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E) Xanthan Gum.
When Using This Product

keep out of eyes

- rinse with water to remove.

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.
Section 42229-5 (42229-5)

Do not store in excessive heat or direct sunlight.

Purpose

Sunscreen

Warnings
  • For external use only.
Directions
  • Apply liberally 15-minutes before sun exposure.
  • Reapply: 
  • At least,every 2 hours.
  • Immediately after swimming, sweating or towel drying.
  • SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, 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, consult a physician.
Do Not Use (Do not use)
  • on damaged or broken skin.
Active Ingredient

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Package Labeling:

Inactive Ingredients
  • Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E) Xanthan Gum.
When Using This Product (When using this product)

keep out of eyes

- rinse with water to remove.

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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