FDA.reportPublic FDA data

MALIE ORGANICS REEF SAFE SUNSCREEN SPF-30

Manufacturer
Malie, Inc.
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:21:06

Label at a glance#

ProductMALIE ORGANICS REEF SAFE SUNSCREEN SPF-30
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure7 sections

Indications and 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

Dosage and administration

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 oth...

Label contents#

Full prescribing information#

Active-Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octisalate 5%

Zinc-Oxide 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

not intended for ingestion. For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and laste.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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:

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73731-08273731-082-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ANNATTO6PQP1V1B6OIACT
BROMELAINSU182GP2CF3IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARNAUBA WAXR12CBM0EIZIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
SAFFLOWER4VBL71TY4YIACT
COCONUT OILQ9L0O73W7LIACT
TURMERIC856YO1Z64FIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
AVOCADO OIL6VNO72PFC1IACT
POMEGRANATE56687D1Z4DIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2550f829-261e-960d-e063-6394a90a9cc3fbe1bb93-a52f-4c74-8a0e-cf5c2ea4aa1a2024-10-25WarningsExact identifier
spl set id: fbe1bb93-a52f-4c74-8a0e-cf5c2ea4aa1a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.