FDA.reportPublic FDA data

Reef Repair Sunscreen SPF 40

Manufacturer
Alive 2 Dive Co Ltd
Effective date
2024-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:41

Label at a glance#

ProductReef Repair Sunscreen SPF 40
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn 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

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure Apply to all skin exposed to the sun Apply to dry skin 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 rish of skin cancer and early skin aging. To decrease this risk, regularly use a suncree...

Storage and handling

Protect the product in this container from excessive heat and direct sun May stain some fabrics

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 20%

Titanium dioxide 2.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

When using this product

OTC - WHEN USING SECTION

when using this product keep out of eyes. Rinse with water to remove

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure
  • Apply to all skin exposed to the sun
  • Apply to dry skin
  • 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 rish of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun
  • May stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Helianthus annuus (Sunflower seed) oil

Caprylic/Capric Triglyceride

Coco Caprylate

Cera alba (Beeswax)

Isoamyl Laurate

Limonia Acidissim (Thanaka) powder

Polyglyceryl 3 Polyricinoleate

Tocopherol Acetate (Vitamin E)

Stearic acid

Alumina

OTC - QUESTIONS SECTION

  • Natural reef safe formula
  • Broad Spectrum SPF 40
  • PA+++
  • Moisturizing
  • Water resistant (80 Minutes)
  • Applies Clear
  • Contains no harmful chemicals, parabens, dyes or silicones
  • Cruelty free ( Not tested on animals)
  • Kid Friendly

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73541-003-012025-07-29C16284748780-13b156c62-2969-fb37-e063-e6dba90a4e07Reef Repair Sunscreen SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73541-003-01Reef Repair Sunscreen SPF 40120 mL in 1 TUBECREAM1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73541-003REEF REPAIR SUNSCREEN SPF 40 (ZINC OXIDE/TITANIUM DIOXIDE) CREAM [ALIVE 2 DIVE CO LTD]11 package rows20240518_18a11582-416f-d448-e063-6294a90a1d95.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73541-00373541-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
SUNFLOWER OIL3W1JG795YIIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCO-CAPRYLATE4828G836N6IACT
YELLOW WAX2ZA36H0S2VIACT
LIMONIA ACIDISSIMA WHOLEMU5C4X2819IACT
ALUMINUM OXIDELMI26O6933IACT
ZINC OXIDESOI2LOH54ZACTIB
ISOAMYL LAURATEM1SLX00M3MIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

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
18a11582-4170-d448-e063-6294a90a1d9518a11582-416f-d448-e063-6294a90a1d952024-05-17WarningsExact identifier
spl id: 18a11582-4170-d448-e063-6294a90a1d95
spl set id: 18a11582-416f-d448-e063-6294a90a1d95

Reported adverse events (FAERS/openFDA)#

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