Drug Facts

Active Ingredients

Octocrylene 5.00%

Octisalate 5.00%

Zinc Oxide 4.00%

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:

• 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 irritation or rash develops.

Keep out of reach of children.

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

If pregnant or breast-feeding,

• ask a health professional before use.

Directions:

• Apply well 15-minuets before sun exposure • Reapply atleast every two hours. Immediately after drying swimming, or sweating. Spending time in the sun increases your risk of 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 sun between 10am–2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician. SUN PROTECTION MEASURES:

Other Information:

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

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/- Capric Triglyceride, Citric Acid, Cyclopentasiloxane, Cyclotetrasiloxane, Dacus Carota Sativa (Carrot) Extract, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dimethicone, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Punica Granatum (Pomegranate) Extract, Sclerocarya Birrea (Marula) Oil, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

Package Labeling:

Label Label2

EIGHT SAINTS CHASE THE SUN SPF-30
octocrylene, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82247-384
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 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	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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CARROT (UNII: L56Z1JK48B)
WATERMELON (UNII: 231473QB6R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYALURONIC ACID (UNII: S270N0TRQY)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82247-384-00	1 in 1 BOX	02/14/2022
1		59 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/14/2022

Labeler - BRICKELL BRANDS LLC (081141606)

EIGHT SAINTS Chase The Sun SPF-30