FDA.reportPublic FDA data

SPF 50 MINERAL SUNSCREEN LIP

Manufacturer
Guangzhou Tata Biotechnology Co., Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:27:41

Label at a glance#

ProductSPF 50 MINERAL SUNSCREEN LIP
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 4.85%
Titanium Dioxide 8%

OTC - PURPOSE SECTION

Sunscreen

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 agingcaused by the sun.

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 occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.lf swallowed, getmedical help or contact Posion Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

·Applyliberally15 minutes before sun exposure·Reapply:·after 80 minutes of swimming orsweating·after towel drying, swimming, or·at least every 2 hours ·children under 6 months of age: ask a doctor.

OTHER SAFETY INFORMATION

.Protect this product from excessive heat and direct sun.Sun alert: Limiting sunexposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects ofthe sun.

INACTIVE INGREDIENT SECTION

Water,Dimethicone, lsohexadecane, EthylhexylPalmitate, Butylene Glycol, Glycerin, lsopropyl PalmitateSorbitan Sesquioleate, Cetyl Peg/Ppg-10/ Dimethicone.Silica, Disteardimonium Hectorite, Sodium Chloride,Trimethylsiloxysilicate, Peg-30 Dipolyhydroxystearate,

Tribehenin, Magnesium Stearate, Phenoxyethanol,Triethoxycaprylylsilane Ethylhexylglycerin, PentaerythrityTetra-Di-T-Buty Hydroxyhydrocinnamate

OTC - QUESTIONS SECTION

Please call:1-817-398-8817 or emus at info@redi-usa.com.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84066-104-01SPF 50 MINERAL SUNSCREEN LIP29.6 mL in 1 BOTTLECREAM29.63

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84066-10484066-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ETHYLHEXYL PALMITATE2865993309IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ISOHEXADECANE918X1OUF1EIACT
GLYCERINPDC6A3C0OXIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
TRIBEHENIN8OC9U7TQZ0IACT
MAGNESIUM STEARATE70097M6I30IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
SPF 50 MINERAL SUNSCREEN LIPZINC OXIDE , TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1c6f0964-9bee-1c06-e063-6294a90ac2a42025-12-22WarningsExact identifier
ndc (package): 84066-104-01
ndc (product): 84066-104
ndc11 (package): 84066010401
spl id: 46872f1f-b25a-abbb-e063-6394a90a0e8f
spl set id: 1c6f0964-9bee-1c06-e063-6294a90ac2a4

Reported adverse events (FAERS/openFDA)#

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