FDA.reportPublic FDA data

Sunglaze Body Gel Cream Sunscreen SPF50

Manufacturer
Koco Life LLC | ENGLEWOOD LAB, INC.
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:13:13

Label at a glance#

ProductSunglaze Body Gel Cream Sunscreen SPF50
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
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 & early skin aging caused by the sun.

Dosage and administration

• Apply generously and evenly onto the skin, from the neck down. Apply 15 min before sun exposure and reapply every 2 hours. • Reapply: At least every 2 hour. Use a water resistant sunscreen if swimming or sweating. • Sun Protection Measures Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or highe...

Storage and handling

Protect this product from excessive heatand direct sun • May stain some fabrics

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 4%

Homosalate 3%

Octisalate 3%

Octocrylene 3%

Purpose

OTC - PURPOSE SECTION

Avobenzone 4%..................................Sunscreen

Homosalate 3%..................................Sunscreen

Octisalate 3%..................................Sunscreen

Octocrylene 3%..................................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 & early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only

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 a rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply generously and evenly onto the skin, from the neck down. Apply 15 min before sun exposure and reapply every 2 hours. • Reapply: At least every 2 hour. Use a water resistant sunscreen if swimming or sweating. • Sun Protection Measures Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, hats, and sunglasses • Children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Propanediol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Acrylates Copolymer, 1,2-Hexanediol, Hydrogenated Poly(C6-20 Olefin), Ethyl Ferulate, Fragrance (Parfum), Niacinamide, Pongamia Pinnata Seed Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroxyacetophenone, Tromethamine, Hdi/Trimethylol Hexyllactone Crosspolymer, Eugenia Caryophyllus (Clove) Bud Extract, Solidago Virgaurea (Goldenrod) Extract, Caprylyl Glycol, Carrageenan, Rhus Verniciflua Peel Wax, Mica, Octyldodecanol, Eclipta Prostrata Extract, Glycine Soja (Soybean) Oil, Titanium Dioxide (CI 77891), Melia Azadirachta Leaf Extract, Pentylene Glycol, Moringa Oleifera Seed Oil, Sodium Acetylated Hyaluronate, Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydrolyzed Sodium Hyaluronate, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Ethylhexylglycerin, Tocopherol, Benzyl Salicylate, Hexyl Cinnamal, Linalool

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heatand direct sun • May stain some fabrics

Questions/Comments?

OTC - QUESTIONS SECTION

Call (858) 252-0099

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kopari

Sunglaze

Body Gel Cream

Sunscreen SPF 50+

Broad Spectrum UVA-UVB

3.4 Fl Oz | 100ML

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84130-017-33Sunglaze Body Gel Cream Sunscreen SPF50100 mL in 1 TUBECREAM1001

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84130-01784130-017-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA-CAROTENE01YAE03M7JIACT
ETHYL FERULATE5B8915UELWIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
CLOVEK48IKT5321IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
OCTISALATE4X49Y0596WACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
ECLIPTA PROSTRATA LEAFH86R96580EIACT
MELIA AZADIRACHTA LEAFHKY915780TIACT
NIACINAMIDE25X51I8RD4IACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
SOLIDAGO VIRGAUREA WHOLEF45YHM06JEIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CARROTL56Z1JK48BIACT
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
HYDROGENATED POLY(C6-20 OLEFIN)39EYQ1W9RBIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLESWZ7DY7GBV6IACT
HEXYL CINNAMAL7X6O37OK2IIACT
MICAV8A1AW0880IACT
MORINGA OLEIFERA SEED OILREM6A5QMC0IACT
OCTYLDODECANOL461N1O614YIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CARRAGEENAN5C69YCD2YJIACT
RHUS VERNICIFLUA PEEL WAX6RG2461FCHIACT
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER788QAG3W8AIACT
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
LINALOOLD81QY6I88EIACT
PENTYLENE GLYCOL50C1307PZGIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TOCOPHEROLR0ZB2556P8IACT
TROMETHAMINE023C2WHX2VIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYALURONATEYSE9PPT4THIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT

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
Sunglaze Body Gel Cream Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC3e6658a1-ae6a-9d19-e063-6294a90acae72025-09-09WarningsExact identifier
ndc (package): 84130-017-33
ndc (product): 84130-017
ndc11 (package): 84130001733
spl id: 3e6658a1-ae6b-9d19-e063-6294a90acae7
spl set id: 3e6658a1-ae6a-9d19-e063-6294a90acae7

Reported adverse events (FAERS/openFDA)#

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