FDA.reportPublic FDA data

SUN PROTECT LIP BALM SPF 30

Manufacturer
Stream2Sea, LLC
Effective date
2025-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:52:28

Label at a glance#

ProductSUN PROTECT LIP BALM SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours. For children under 6 months of age; ask a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients

Non Nano Zinc Oxide 6%, Non Nano Titanium Dioxide 7%

OTC - PURPOSE SECTION

Purpose
Sunscreen

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.
  • When using this product, keep out of eyes. Rinse with water to remove.
  • Keep out of reach of children, If swallowed, get medical help or contact a poison control centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
  • For children under 6 months of age; ask a doctor.

OTHER SAFETY INFORMATION

Other information

  • This is a personal care item, and should be used by one individual only.
  • Protect this product from excessive heat and direct sun.
  • Do not use if safety seal is broken prior to purchase.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sun Protected Lip Balm SPF 30 + - Naturally Naked

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea) Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifers (Carnuba) Wax, Cetyl Esters, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter.

Sun Protected Lip Balm SPF 30 + - Cherry Vanilla

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa(Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl esters, Cherry Vanilla Flavor* Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.
*Flavor is certified all natural.

Sun Protected Lip Balm SPF 30 + - Cucumber Mint

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil , Candelilla Cera wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl Esters, Cucumber Mint Flavor* Glyceryl Caprylate, Helianthus Annuus(Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.
*Flavor is certified all natural.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUN PROTECT LIP BALM NATURALLY NAKED SPF 30 + 0.15 OZ - Label - NDC - 69555-036-01

SUN PROTECT LIP BALM NATURALLY NAKED - Label
SUN PROTECT LIP BALM NATURALLY NAKED - Label

SUN PROTECT LIP BALM CUCUMBER MINT SPF 30 + 0.15 OZ - Label - NDC - 69555-036-02

SUN PROTECT LIP BALM CUCUMBER MINT - Label
SUN PROTECT LIP BALM CUCUMBER MINT - Label

SUN PROTECT LIP BALM CHERRY VANILLA SPF 30 + 0.15 OZ - Label - NDC - 69555-036-03

SUN PROTECT LIP BALM CHERRY VANILLA - Label
SUN PROTECT LIP BALM CHERRY VANILLA - Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69555-036-04SUN PROTECT LIP BALM SPF 304 g in 1 TUBECREAM43
69555-036-05SUN PROTECT LIP BALM SPF 304 g in 1 TUBECREAM43
69555-036-06SUN PROTECT LIP BALM SPF 304 g in 1 TUBECREAM43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69555-036SUN PROTECT LIP BALM SPF 30 (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [STREAM2SEA, LLC]3Current NDC, Legacy NDC, 3 package rows20250114_21386652-b952-48be-b077-1acecc7f0eb0.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69555-03669555-036-04, 69555-036-05, 69555-036-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
HOLY BASIL LEAFSCJ765569PIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
CANDELILLA WAXWL0328HX19IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ESTERS WAXD072FFP9GUIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SUNFLOWER OIL3W1JG795YIIACT
MICAV8A1AW0880IACT
TOCOPHEROLR0ZB2556P8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STARCH, RICE4DGK8B7I3SIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITAN OLIVATEMDL271E3GRIACT
COCOA BUTTER512OYT1CRRIACT

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
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
ndc (package): 69555-036-05
ndc (package): 69555-036-04
ndc (package): 69555-036-06
ndc (product): 69555-036
ndc11 (package): 69555003605
ndc11 (package): 69555003606
ndc11 (package): 69555003604
spl id: 2b89ca67-2b93-06f8-e063-6294a90a2b3e
spl set id: 21386652-b952-48be-b077-1acecc7f0eb0

Reported adverse events (FAERS/openFDA)#

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