FDA.reportPublic FDA data

REEF SAFE Unscented SPF Mineral Sunscreen

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:40:20

Label at a glance#

ProductREEF SAFE Unscented SPF Mineral Sunscreen 01
Active ingredientOCTOCRYLENE, HOMOSALATE, AVOBENZONE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn Higher SPF giwes more sunburn protection

Dosage and administration

apply liberally 15minutes before sun exposure as needed Children under 6 months of age: ask a doctor before use. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other s...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF giwes more sunburn protection

Warnings

WARNINGS SECTION

For external use only

Skin Cancer/Skin Aging Alert:

WARNINGS AND PRECAUTIONS SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sumburn, not skin cancer or early skin aging.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation develops and persists.

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 15minutes before sun exposure as needed
  • Children under 6 months of age: ask a doctor before use.
  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10a.m.- 2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA(WATER), ISONONYL ISONONANOATE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CETETH-25, CETEARYL ALCOHOL, SILICA, VP/HEXADECENE COPOLYMER, GLYCERYL STEARATE, PEG-100 STEARATE, PHENOXYETHANOL, TOCOPHEROL, XANTHAN GUM, PVP, ETHYLHEXYLGLYCERIN, GLYCINE MAX (SOYBEAN) OIL, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-02782953-027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-027-01REEF SAFE Unscented SPF Mineral Sunscreen0145 mL in 1 BOTTLE, PLASTICCREAM451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-027REEF SAFE UNSCENTED SPF MINERAL SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) CREAM [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 1 package rows20241206_286965aa-0961-0141-e063-6394a90aa3f0.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-02782953-027-01

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
GLYCERINPDC6A3C0OXIACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
TOCOPHEROLR0ZB2556P8IACT
PVPFZ989GH94EIACT
GLYCINE MAX (SOYBEAN) OIL241ATL177AIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-255KLY4IOG20IACT
EDETATE DISODIUM7FLD91C86KIACT
PEG-100 STEARATEYD01N1999RIACT
WATER059QF0KO0RIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIMETHICONE92RU3N3Y1OIACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SILICAETJ7Z6XBU4IACT

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
REEF SAFE Unscented SPF Mineral Sunscreen 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.286965aa-0961-0141-e063-6394a90aa3f02024-12-03WarningsExact identifier
ndc (package): 82953-027-01
ndc (product): 82953-027
ndc11 (package): 82953002701
spl id: 28694a6c-d0f7-ef19-e063-6394a90a8c89
spl set id: 286965aa-0961-0141-e063-6394a90aa3f0

Reported adverse events (FAERS/openFDA)#

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