Brickell Element Defense Moisturizer Spf-45

Brickell Element Defense Moisturizer Spf-45
SPL v2
SPL
SPL Set ID 94be278a-3773-469b-8e40-3242d1072a3d
Route
TOPICAL
Published
Effective Date 2021-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Octisalate (50 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Watermelon Decyl Glucoside Ethylhexylglycerin Glycerin Sunflower Oil C13-14 Isoparaffin Laureth-7 Phenoxyethanol .alpha.-tocopherol Acetate Tridecyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-21
Description

Octocrylene 10.00% Octisalate 5.00% Zinc Oxide 5.00%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octocrylene 10.00% Octisalate 5.00% Zinc Oxide 5.00%

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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.

Warnings:

not intended for ingestion For external use only

Do Not Use

  • on damaged or broken skin.

Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every2 hourr
  • 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 SPF of 15 or higher, along with other sun protection measues including: SUN PROTECTION MEASURES:
  • Limit time in the sun, especially between 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
Package Labeling:

Active Ingredients

Octocrylene 10.00% Octisalate 5.00% Zinc Oxide 5.00%



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

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lantatus (Watermelon) Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, polyacrylamide, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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

Warnings:

not intended for ingestion For external use only

Do Not Use (Do not use)

  • on damaged or broken skin.

Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every2 hourr
  • 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 SPF of 15 or higher, along with other sun protection measues including: SUN PROTECTION MEASURES:
  • Limit time in the sun, especially between 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
Package Labeling:

Active Ingredients

Octocrylene 10.00% Octisalate 5.00% Zinc Oxide 5.00%



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

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lantatus (Watermelon) Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, polyacrylamide, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.969659 · Updated: 2026-03-14T23:01:49.492831