FDA.reportPublic FDA data

HYDRATING LIP BALM SUNSCREEN

Manufacturer
Dimensional Merchandising Inc.
Effective date
2018-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:58:40

Label at a glance#

ProductHYDRATING LIP BALM SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure11 sections

Indications and 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

Dosage and administration

• apply generously and evenly to lips 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating •  Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:     •...

Storage and handling

• protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 2.7%

Purpose

OTC - PURPOSE SECTION

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 and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• apply generously and evenly to lips 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m.- 2p.m.

    • wear long-sleeved shirts, pants, hats and sunglasses

• children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Bis-Diglyceryl Polyacyladipate-2, Caprylic/Capric Triglyceride, Beeswax, Ozokerite, Polyisobutene, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Flavor, Dipotassium Glycyrrhizate, Vaccinium Myrtillus Seed Oil, Alcohol, Water (Aqua), Glycerin, Zanthoxylum Bungeanum Fruit Extract, Sarracenia Leucophylla Flower/Leaf/Seed/Stalk Extract, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Hypericum Perforatum Flower/Leaf Extract, Camellia Sinensis Leaf Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Sodium Lauroyl Lactylate, Melissa Officinalis Extract, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Xanthan Gum, Carbomer, Ceramide EOP

Other information

STORAGE AND HANDLING SECTION

• protect the product in this container from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call Toll-Free 1-844-My-Aubio (1-844-692-8246)

Monday-Friday 9am-5pm ET

SPL UNCLASSIFIED SECTION

UVA/UVB Protection

BROAD STECTRUM SPF 30

moisturizes and conditions dry lips

AubioTM Hydrating Lip Balm provides BROAD STECTRUM SPF 30 protection while moisturizing and conditioning dry lips

Aubio Life SciencesTM

www.aubio.com

Patent Pending

Distributed by Aubio Life Sciences, LLC

Wixom, MI 48393

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrating Lip BalmHydrating Lip Balm

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61383-24861383-248-15, 61383-248-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WHITE WAX7G1J5DA97FIACT
CERESINQ1LS2UJO3AIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
CARNAUBA WAXR12CBM0EIZIACT
CANDELILLA WAXWL0328HX19IACT
SUNFLOWER OIL3W1JG795YIIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
BILBERRY SEED OILKK0KHX972KIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
SARRACENIA PURPUREAFOP08H143PIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
LICORICE61ZBX54883IACT
ST. JOHN'S WORTUFH8805FKAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ELEUTHEROZQH6VH092ZIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
MELISSA OFFICINALISYF70189L0NIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CERAMIDE 15THT33P7X7IACT

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
f3653143-007e-494e-b9be-b72e61389c060d51897e-024a-4ecf-a3e0-295fa038a1302023-06-07WarningsExact identifier
spl set id: 0d51897e-024a-4ecf-a3e0-295fa038a130

Reported adverse events (FAERS/openFDA)#

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