MALIE ORGANICS REEF SAFE SUNSCREEN SPF-30- homosalate, octisalate, zinc oxide cream 
Malie, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MALIE ORGANICS REEF SAFE SUNSCREEN SPF-30

Drug Facts

Active-Ingredients

Homosalate 10%

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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only not intended for ingestion.

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, Lecithin, Parfum (Fragrance), Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract.

Package Labeling:

Label

MALIE ORGANICS REEF SAFE SUNSCREEN SPF-30 
homosalate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73731-082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73731-082-05150 mL in 1 TUBE; Type 0: Not a Combination Product03/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/20/2020
Labeler - Malie, Inc. (164892056)

Revised: 3/2020
 
Malie, Inc.