FDA.reportPublic FDA data

Reef Repair SPF 50

Manufacturer
Alive 2 Dive Company Limited
Effective date
2024-04-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:52

Label at a glance#

ProductReef Repair SPF 50 Suncream
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally and evenly to dry skin 15 minutes before sun exposure Apply to all skin exposed to the sun Reapply: After 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours Sun Proctection Measures: Spending time in the sun increases your risk of skin cance and early skin aging. To decrease this risk, regularly use a sunscreen with a Broas Spectrum SPF calue of 15 or higher ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide: 25%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly to dry skin 15 minutes before sun exposure
  • Apply to all skin exposed to the sun
  • Reapply: After 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
  • Sun Proctection Measures: Spending time in the sun increases your risk of skin cance and early skin aging. To decrease this risk, regularly use a sunscreen with a Broas Spectrum SPF calue 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

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 if

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

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Aqua, Cocos nuciera (Coconut oil), Persea gratissma (Avocado oil), Cetearyl alcohol / Polysorbate 60 (Vegatable emulsifying wax NF), Butyrospernum parkii (Shea butter), Rubus idaeus (Red Raspberry seed oil), Glyceryl Oleate Citrate & Caprylic / Capric Triglyceride, Glycerin, Cera alba (Beeswax), Ethylhexylglycerin & Propanediol, Polyhydoxystearic acid, Sodium Gluconate, Cocos nucifera (Coconut essential oil), Vanilla plantifolia (Vanilla essential oil)

Other Information

OTHER SAFETY INFORMATION

Other Information

  • 100 % biodegradable non-toxic, reef safe formula
  • Contains no harmful chemicals, parabens or silicones
  • Broad Spectrum SPF 50
  • PA+++
  • Moisturizing
  • Cruelty free (Non tested on animals)
  • Water resistant (80 Minutes)

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73541-000-012025-07-29C16284748780-1ba0f9c33-49e6-a910-e053-dadaa90a0b85Reef Repair Suncream SPF 50+
73541-000-012021-10-06C16284748780-1ba0f9c33-49e6-a910-e053-dadaa90a0b85Reef Repair Suncream SPF 50+
73541-000-012021-01-29C16284748780-1ba0f9c33-49e6-a910-e053-dadaa90a0b85Reef Repair Suncream SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73541-000-01Reef Repair SPF 50Suncream120 mL in 1 BOTTLECREAM1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73541-000REEF REPAIR SPF 50 SUNCREAM (ZINC OXIDE, 25%) CREAM [ALIVE 2 DIVE COMPANY LIMITED]4Legacy NDC, 1 package rows20240410_995bb918-ffbc-3660-e053-2a95a90a1f82.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73541-00073541-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
WHITE WAX7G1J5DA97FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
VANILLA PLANIFOLIA OIL0A3F415158IACT
COCOS NUCIFERA WHOLE245J88W96LIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
SODIUM GLUCONATER6Q3791S76IACT
TRICAPRINO1PB8EU98MIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPANEDIOL5965N8W85TIACT
AVOCADO OIL6VNO72PFC1IACT
RASPBERRY SEED OIL9S8867952AIACT
GLYCERYL OLEATE4PC054V79PIACT
ZINC OXIDESOI2LOH54ZACTIB

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
158def0e-9f6a-75ed-e063-6294a90a647a995bb918-ffbc-3660-e053-2a95a90a1f822024-04-07WarningsExact identifier
spl id: 158def0e-9f6a-75ed-e063-6294a90a647a
spl set id: 995bb918-ffbc-3660-e053-2a95a90a1f82

Reported adverse events (FAERS/openFDA)#

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