the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium dark

Manufacturer: Columbia Cosmetics Manufacturing, Inc.
Effective date: 2019-10-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:06:46

Label at a glance#

Productthe Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium dark

Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE

Label structure10 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 liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor. Sun Protection Measures. 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 of 15 or higher and other sun protection measures including: li...

Contacts and useful links#

Websitewww.thebalm.com

www.theBalm.com

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE (7.5%)
OCTISALATE (3.0%)
AVOBENZONE (3.0%)

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

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

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
children under 6 months: Ask a doctor.
Sun Protection Measures. 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 of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 AM - 2 PM.
wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients:

INACTIVE INGREDIENT SECTION

WATER (AQUA) - CETEARYL ALCOHOL - lSOPROPYL MYRISTATE - CETYL DIMETHICONE - DIMETHICONE - HEXYL LAURATE - POTASSIUM CETYL PHOSPHATE - HYDROXYETHYL ACRYLATE-SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - lSOHEXADECANE - POLYSORBATE 60 - STYRENE-DVB CROSSPOLYMER - SORBITAN SESQUIOLEATE - PHENOXYETHANOL - CAPRYLYL GLYCOL - ETHYLHEXYL GLYCERIN - HEXYLENE GLYCOL - SODIUM DEHYDROACETATE MAY CONTAIN: TITANIUM DIOXIDE CI 77891 - IRON OXIDES CI 77491 - CI 77492 - CI 77499

Other information:

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

the Balm cosmetics SPF 18

SPL UNCLASSIFIED SECTION

Balm Shelter the Balm tinted moisturizer SPF 18 - hydratant

Designed for all skin types. This weightless silky smooth tinted moisturizer SPF 18 offers lasting moisture and helps to improve the tone and texture of your skin, leaving you with a polished complexion. Apply to clean face.

Please recycle this box. 24 M

the Balm - San Francisco, CA 94123, USA www.theBalm.com
theBalm's (Cosmetics) LTD 64 Sutton Park, Sutton, Dublin 13 Ireland
Made in the USA.

Sun Protection for Everyday Drama

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Balm Shelter tinted moisturizer SPF 18 broad spectrum the Balm

64 mL e 2.15 FL. OZ. US

the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium/dark 64ml (61016-0005-0)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medium Dark LabelInner LabelOuter Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61016-0005-0	2022-01-28	C162847	48780-1	d6a99b39-50e3-a426-e053-dadaa90af4c2	the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium/dark

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	1
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	1
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	1
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	1
STYRENE	INACTIVE INGREDIENT	44LJ2U959V	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium dark
OCTINOXATE, OCTISALATE, AVOBENZONE
WATER
CETOSTEARYL ALCOHOL
ISOPROPYL MYRISTATE
DIMETHICONE
HEXYL LAURATE
POTASSIUM CETYL PHOSPHATE
ISOHEXADECANE
POLYSORBATE 60
STYRENE
SORBITAN SESQUIOLEATE
PHENOXYETHANOL
CAPRYLYL GLYCOL
ETHYLHEXYLGLYCERIN
HEXYLENE GLYCOL
SODIUM DEHYDROACETATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
OCTINOXATE
OCTISALATE
AVOBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61016-0005	61016-0005-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
DIMETHICONE	92RU3N3Y1O	IACT
HEXYL LAURATE	4CG9F9W01Q	IACT
POTASSIUM CETYL PHOSPHATE	03KCY6P7UT	IACT
ISOHEXADECANE	918X1OUF1E	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
STYRENE	44LJ2U959V	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
HEXYLENE GLYCOL	KEH0A3F75J	IACT
SODIUM DEHYDROACETATE	8W46YN971G	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 143 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITAN SESQUIOLEATE	SORBITAN SESQUIOLEATE	0W8RRI5W5A	OINTMENT / TOPICAL		75 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / TOPICAL	2.85 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / RECTAL	0.05 mg/mg		Exact identifier — unii candidate 13 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 18 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
951cb4b7-01e6-31ee-e053-2995a90a149f			1d020b69-7fa1-4102-9e71-93014d75dc8a	2019-10-17	Warnings	Exact identifier spl id: 951cb4b7-01e6-31ee-e053-2995a90a149f spl set id: 1d020b69-7fa1-4102-9e71-93014d75dc8a

Reported adverse events (FAERS/openFDA)#

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