FDA.reportPublic FDA data

All Good Broad Spectrum SPF 15 Spearmint Lip Balm

Manufacturer
Raining Rose, Inc.
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:47

Label at a glance#

ProductAll Good Broad Spectrum SPF 15 Spearmint Lip Balm
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Medicinal ingredients: Zinc Oxide 3.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Risk Information • For external use only • Do not use on damaged or broken skin • If rash occurs, discontinue use and consult a health care practitioner • When using this product keep out of eyes. • Rinse with water to remove.

Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, skin cancer or early skin aging.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions • Apply liberally/generously (and evenly) 15 minutes before sun exposure. • Reapply: • at least every 2 hours • after 80 minutes of swimming or sweating • immediately after towel drying • after eating or drinking • For use on children less than 6 months of age, consult a health care practitioner. 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.,-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT SECTION


Non-medicinal Ingredients: Organic Olea Europaea (Extra Virgin Olive) Fruit Oil, Cera Alba (Beeswax), Organic Calendula Officinalis (Calendula) Flower, Organic Symphytum Officinale (Comfrey) Leaf, Organic Plantago Lanceolata (Plantain) Leaf, Organic Lavandula Angustifolia (Lavender) Flower, Organic Achillea Millefolium (Yarrow) Flower, Organic Mentha Spicata (Spearmint Essential Oil), Non-GMO Tocopherol (Vitamin E).

Product Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BROAD SPECTRUM SPF 15

ALL

good

SPEARMINT

lip balm

Net wt 0.15 oz (4.2 g)

P.O. BOX 203, MORRO BAY, CA 93443 | ALLGOODBODYCARE.COM

0313 spearmint0313 spearmint

res

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0313-1All Good Broad Spectrum SPF 15 Spearmint Lip Balm4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0313ALL GOOD BROAD SPECTRUM SPF 15 SPEARMINT LIP BALM (BROAD SPECTRUM SPF 15 SPEARMINT LIP BALM) STICK [RAINING ROSE, INC.]2Current NDC, 1 package rows20231104_77370d4e-6888-4cb7-b6b9-1011a71dbf7a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-031365692-0313-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
COMFREY LEAFDG4F8T839XIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
SPEARMINT OILC3M81465G5IACT
TOCOPHEROLR0ZB2556P8IACT

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
All Good Broad Spectrum SPF 15 Spearmint Lip BalmBROAD SPECTRUM SPF 15 SPEARMINT LIP BALMRaining Rose, Inc.77370d4e-6888-4cb7-b6b9-1011a71dbf7a2023-11-03WarningsExact identifier
ndc (package): 65692-0313-1
ndc (product): 65692-0313
ndc11 (package): 65692031301
spl id: 1998d509-e5c1-4148-a84e-8eec4e9e79d5
spl set id: 77370d4e-6888-4cb7-b6b9-1011a71dbf7a

Reported adverse events (FAERS/openFDA)#

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