Western FAMILY

Manufacturer: WESTERN FAMILY FOODS, INC. | Playtex Manufacturing Inc
Effective date: 2014-07-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:39:42

Label at a glance#

ProductWestern FAMILY SPF 15

Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Label structure12 sections

Indications and uses

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

Dosage and administration

apply liberally 15 minutes before sun exposure reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 of 15 or higher and other sun protection measures including: limit time in the sun, e...

Contacts and useful links#

PhoneLabel contact1-503-639-6300

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decrease 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

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. May stain some fabrics.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure
reapply
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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 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-sleeve shirts, pants, hats and sunglasses
children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Carbomer, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Chlorphenesin, Fragrance.

Other Information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WESTERN FAMILY

Broad Spectrum

SPF 15

sunscreen lotion

UVA/UVB protection

moisturizing with vitamin e

water resistant

(80 minutes)

10 FL OZ (295 mL)

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-503-639-6300

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55312-017-57	2020-01-31	C162847	48780-1	9d75b9d0-4726-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55312-017-57	Western FAMILYSPF 15	290 g in 1 BOTTLE, PLASTIC	LOTION	290		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55312-017	WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.]	2	Legacy NDC, 1 package rows	20140707_dda7975f-29f2-4870-89cc-cea8828b64e4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	2
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	2
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	2
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	2
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Western FAMILY SPF 15
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
AVOBENZONE
HOMOSALATE
OCTISALATE
OCTOCRYLENE
WATER
ETHYLHEXYL PALMITATE
SORBITOL
BENZYL ALCOHOL
DIMETHICONE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
TROLAMINE
EDETATE DISODIUM
TOCOPHEROL
ALOE VERA LEAF
CHLORPHENESIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55312-017	55312-017-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
WATER	059QF0KO0R	IACT
ETHYLHEXYL PALMITATE	2865993309	IACT
SORBITOL	506T60A25R	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
TROLAMINE	9O3K93S3TK	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
TOCOPHEROL	R0ZB2556P8	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CHLORPHENESIN	I670DAL4SZ	IACT

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 4 · 222 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAVENOUS		242 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / SUBCUTANEOUS		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / VAGINAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / SUBCUTANEOUS	0.95 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / RECTAL	129 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRA-ARTICULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE / ORAL		450 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii candidate 50 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
192ccbf8-52eb-4781-9465-d3b7c430d803			dda7975f-29f2-4870-89cc-cea8828b64e4	2014-07-07	Warnings	Exact identifier spl id: 192ccbf8-52eb-4781-9465-d3b7c430d803 spl set id: dda7975f-29f2-4870-89cc-cea8828b64e4

Reported adverse events (FAERS/openFDA)#

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