Drug Facts

Active Ingredients

Octocrylene 10.00% Octisalate 5.00% Zinc Oxide 5.00%

Purpose

Sunscreen

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.

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.

If pregnant or breast-feeding,

ask a health professional before use.

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.

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.

Other Information:

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Label

BRICKELL ELEMENT DEFENSE MOISTURIZER SPF-45
octocrylene, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82247-234
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATERMELON (UNII: 231473QB6R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82247-234-00	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	09/21/2021

Labeler - BRICKELL BRANDS LLC (081141606)

BRICKELL Element Defense Moisturizer SPF-45