Drug Facts

Active-Ingredients

Homosalate 10%

Octocrylene 8%

Octisalate 5%

Zinc-Oxide 5%

Purpose

Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more sunburn protection
Retains SPF for 80 minutes of swimming or sweating
If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 laste.

Keep out of reach of children.

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

Directions

Apply liberally 15 minutes before sun exposure and as needed.
Children under 6 months of age: ask a doctor.
Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am.m -2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in this container from excessive heat & direct sun.
This sustainable packaging is Earth-friendly & made in the USA using sugar cane derived resin, please Recycle this tube.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bixa Orellana (Annatto) Extract, Bromelain (Pineapple), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Carnauba Wax, Caprylyl/Capryl Glucoside, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthron) Oil, Lecithin, Parfum (Fragrance), Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Zemea (Corn) Propanediol.

Package Labeling:

Label2

MALIE ORGANICS REEF SAFE SUNSCREEN SPF-50
homosalate, octocrylene, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73731-083
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 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)
ANNATTO (UNII: 6PQP1V1B6O)
BROMELAINS (UNII: U182GP2CF3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
SAFFLOWER (UNII: 4VBL71TY4Y)
COCONUT OIL (UNII: Q9L0O73W7L)
TURMERIC (UNII: 856YO1Z64F)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
AVOCADO OIL (UNII: 6VNO72PFC1)
POMEGRANATE (UNII: 56687D1Z4D)
CORN (UNII: 0N8672707O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73731-083-05	150 mL in 1 TUBE; Type 0: Not a Combination Product	03/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/20/2020

Labeler - Malie, Inc. (164892056)