Drug Facts

Active Ingredients

Octisalate 5.00%

Zinc Oxide 4.00%

Purpose

Sunscreen

Uses

Helps prevent sunburn
If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external ues 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 consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions

Apply liberally 15-minutes before sun exposure.

Reapply:

At least every two 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 suncreen 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 10 am and 2pm.

Wear long sleeve shirts, pants, hats and sunglasses.

For children under 6-months, consult a physician.

Other Ingredients

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

Package Labeling:

Jar

BRICKELL DAILY DEFENSE FACE MOISTURIZER SPF-20
octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82247-225
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 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)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
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:82247-225-00	59 mL in 1 JAR; 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 Daily Defense Face Moisturizer SPF-20