FDA.reportPublic FDA data

SUNSCREEN SPF50

Manufacturer
Guangzhou Tinsun Biotechnology Company Limited
Effective date
2025-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:39

Label at a glance#

ProductSUNSCREEN SPF50
Active ingredientOCTOCRYLENE, TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ETHYLHEXYL METHOXYCINNAMATE 6%
OCTOCRYLENE 4%
TITANIUM DIOXIDE 2%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Block or absorb ultraviolet rays to preventskin from developing erythema, tanningand aging due to sun exposure

WARNINGS SECTION

Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd

OTC - DO NOT USE SECTION

Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd

OTC - WHEN USING SECTION


Ask a doctor before use if
Photosensitivity skin diseases or taking certain photosensitivity medications

OTC - STOP USE SECTION


Stop use and ask a doctor if
Redness,itching, peeling, or stinging occurs after applying sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION

DOSAGE & ADMINISTRATION SECTION

Take an appropriate amount of sunscreenon the palm of your hand and applyevenly to the face, neck, arms and otherareas exposed to the sun.

INACTIVE INGREDIENT SECTION

WATER
ISONONYL ISONONANOATE
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL
GLYCERIN
BUTYLENE GLYCOL
CYCLOPENTASILOXANE
STEARETH-2
STEARETH-21
CAPRYLIC/CAPRIC TRIGLYCERIDE
TOCOPHERYL ACETATE
ALOE BARBADENSIS LEAF EXTRACT
PORTULACA OLERACEA EXTRACT
POLYSORBATE 80
RUTIN
BETA-GLUCAN
1,2-HEXANEDIOL
HYDROXYACETOPHENONE
XANTHAN GUM
ORYZANOL
BISABOLOL
SODIUM HYALURONATE
ALLANTOIN
DISODIUM EDTA
AROMA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85998-001-01SUNSCREEN SPF5050 mL in 1 BOTTLECREAM501

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85998-00185998-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISONONYL ISONONANOATES4V5BS6GCXIACT
OCTOCRYLENE5A68WGF6WMACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
GLYCERINPDC6A3C0OXIACT
AROMATIC-L-AMINO-ACID DECARBOXYLASEBY6OQ7Q6TPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
RUTIN5G06TVY3R7IACT
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85)2YGO1190APIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
XANTHAN GUMTTV12P4NEEIACT
ORYZANOLSST9XCL51MIACT
SODIUM HYALURONATEYSE9PPT4THIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM7FLD91C86KIACT
STEARETH-2V56DFE46J5IACT
WATER059QF0KO0RIACT
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL412ZHA4T4YIACT
STEARETH-2153J3F32P58IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYL METHOXYCINNAMATE4Y5P7MUD51ACTIB
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
PURSLANEM6S840WXG5IACT
BISABOLOL24WE03BX2TIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
POLYSORBATE 806OZP39ZG8HIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT

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
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact identifier
ndc (package): 85998-001-01
ndc (product): 85998-001
ndc11 (package): 85998000101
spl id: 3bc1c6e9-1dd6-d7c6-e063-6394a90ad89e
spl set id: 3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e

Reported adverse events (FAERS/openFDA)#

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