FDA.reportPublic FDA data

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15

Manufacturer
Guangzhou Tata Biotechnology Co., Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:27:40

Label at a glance#

ProductSUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15
Active ingredientOCTINOXATE, OCTOCRYLENE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate 7.5%

Octocrylene 5%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

protect lips from damaging UVA and UVB rays.

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

DOSAGE & ADMINISTRATION SECTION

Step 1:Saueeze tube.

Step 2:Apply liberally and evenly to lips 15 to 20 minutes before exposure to the sun.

Step3:Reapply after periods of swimming exercise and towel drying or as required.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Ethylhexyl Palmitate, Polyisobutene,Petrolatum,Microcrystalline Wax,Hydrogenated Styrene/lsoprene Copolymer,PentaerythritylTetra-Di-T-ButylHydroxyhydrocinnamate,Beeswax, Synthetic Wax, Tocopheryl Acetate, Tridecyl Trimellitate,Simmondsia Chinensis (Jojoba) Seed Oil,Macadamia Integrifolia Seed Oil, Limnanthes Alba(Meadowfoam)Seed Oi,Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil,Phenoxyethanol,Ethylhexylglycerin,Fragrance,FD&C YELLOW NO.5(C119140),TheobromaCacao(Cocoa)Extract,

Dextrin,Phytosteryl/OctyldodecylLauroyl, Glutamate,Tocopherol

OTC - QUESTIONS SECTION

You can email us at info@redi-usa.com for more help!

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84066-103-01SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 1510 mL in 1 TUBEGEL104

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
84066-10384066-103-01

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
ICODEXTRIN2NX48Z0A9GIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
COCOAD9108TZ9KGIACT
YELLOW WAX2ZA36H0S2VIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTINOXATE4Y5P7MUD51ACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
TOCOPHEROLR0ZB2556P8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYLHEXYL PALMITATE2865993309IACT
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW)H58HX2GWJ5IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
MACADAMIA OIL515610SU8CIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
OCTOCRYLENE5A68WGF6WMACTIB

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 LIP PROTECTIONBROAD SPECTRUM SPF 15ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.1c32b019-a038-eb61-e063-6394a90a45f22025-12-22WarningsExact identifier
ndc (package): 84066-103-01
ndc (product): 84066-103
ndc11 (package): 84066010301
spl id: 46871df7-0e77-a3c4-e063-6394a90a82c5
spl set id: 1c32b019-a038-eb61-e063-6394a90a45f2

Reported adverse events (FAERS/openFDA)#

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