FDA.reportPublic FDA data

Big Mood SPF 30 Milky Lip Balm

Manufacturer
Everyday Group Limited
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:45

Label at a glance#

ProductBig Mood SPF 30 Milky Lip Balm
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures: Limit time in the sun, especially ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes, rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  •  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m to 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Flavor, Argania Spinosa Kernal (Argan) Oil, Caprylic/capric Triglyceride, Tocopheryl Acetate, Copernicia Cerifera (Carnauba) Wax, Avena Sativa Kernel (Oat) Oil, Agave Tequilana Stem Extract, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Glyceryl Caprylate, Polyhydroxystearic Acid, Polyglyceryl-3-Polyricinoleate, Isostearic Acid, Lecithin, Glyceryl Undecylenta

Other Information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelInner LabelInner Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72098-004-01Big Mood SPF 30 Milky Lip Balm4.2 g in 1 APPLICATORSTICK4.23
72098-004-01Big Mood SPF 30 Milky Lip Balm1 in 1 CARTONSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72098-004BIG MOOD SPF 30 MILKY LIP BALM (ZINC OXIDE) STICK [EVERYDAY GROUP LIMITED]3Current NDC, Legacy NDC, 2 package rows20231110_c83098af-3cf9-78f6-e053-2995a90a0d01.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72098-00472098-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRICAPRYLIN6P92858988IACT
ARGAN OIL4V59G5UW9XIACT
YELLOW WAX2ZA36H0S2VIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT
METHYL SALICYLATELAV5U5022YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARNAUBA WAXR12CBM0EIZIACT
OATZ6J799EAJKIACT
LEVOMENOL24WE03BX2TIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ISOSTEARIC ACIDX33R8U0062IACT
ZINC OXIDESOI2LOH54ZACTIM

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
Big Mood SPF 30 Milky Lip BalmZINC OXIDEEveryday Group Limitedc83098af-3cf9-78f6-e053-2995a90a0d012023-11-09WarningsExact identifier
ndc (package): 72098-004-01
ndc (product): 72098-004
ndc11 (package): 72098000401
spl id: 09c2d4fa-e9ec-318b-e063-6394a90a6d51
spl set id: c83098af-3cf9-78f6-e053-2995a90a0d01

Reported adverse events (FAERS/openFDA)#

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