Broad-Spectrum SPF-15 Lotion

Manufacturer: Continental Manufacturing Chemist, Inc.
Effective date: 2012-07-08
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:32:37

Label at a glance#

ProductSPF-15 Sunscreen

Active ingredientOCTOCRYLENE, AVOBENZONE

Label structure9 sections

Indications and uses

Helps Prevent Sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reaaply at least every 2 hours

Storage and handling

Store at 20-25C (68-77F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10%

Avobenzone 3%

Uses

INDICATIONS & USAGE SECTION

Helps Prevent Sunburn

Purpose

OTC - PURPOSE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

SPL UNCLASSIFIED SECTION

Do not use

OTC - DO NOT USE SECTION

in eyes, if this happens rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

if skin irritation develops

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

Ask a doctor

OTC - ASK DOCTOR SECTION

before using on children under 6 months

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reaaply at least every 2 hours

Storage

STORAGE AND HANDLING SECTION

Store at 20-25C (68-77F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Gel, Benzyl Alcohol, Carbopol, Cetyl Alcohol, Fragrance, (Glyceryl Stearate and PEG 100 Stearate), Methyl Paraben, PEG-40 Stearate, Phenoxyethanol, (Polyacrylamide and C13-14 Isoparrafin and Laureth-7), Propyl Paraben, Purified Water, Shea Butter, Sodium Hydroxide, Sorbitan Monooleate, Stearic Acid, Tetrasodium Ethylenediaminetatraacetate, Vitamin E

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ProductSPF-15 Labels Labels

Manufactured By

SPL UNCLASSIFIED SECTION

Continental Manufacturing Chemist, Inc.

912 S. State Street, Madrid, IA 50156

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49794-048-99	2019-11-13	C162847	48780-1	97449f38-d550-f6ea-e053-dbdaa90aa703	Broad-Spectrum SPF-15 Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49794-048-99	SPF-15 Sunscreen	1100 L in 1 CONTAINER	LOTION	1100		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49794-048	SPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]	4	Legacy NDC, 1 package rows	20120720_b3ea0417-65c2-46ca-9c52-31376dd85637.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	4
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	4
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	4
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	4
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	4
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	4
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	4
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	4
PEG-40 STEARATE	INACTIVE INGREDIENT	ECU18C66Q7	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	4
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)	INACTIVE INGREDIENT	5F4963KLHS	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	4
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

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

SPF-15 Sunscreen
Octocrylene, Avobenzone
OCTOCRYLENE
AVOBENZONE
ALOE VERA LEAF
BENZYL ALCOHOL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
METHYLPARABEN
PEG-40 STEARATE
PHENOXYETHANOL
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)
PROPYLPARABEN
WATER
SHEA BUTTER
SODIUM HYDROXIDE
SORBITAN MONOOLEATE
STEARIC ACID
EDETATE SODIUM
.ALPHA.-TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49794-048	49794-048-99

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
Name	UNII	Kind
OCTOCRYLENE	5A68WGF6WM	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	IACT
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PEG-40 STEARATE	ECU18C66Q7	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)	5F4963KLHS	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SHEA BUTTER	K49155WL9Y	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
STEARIC ACID	4ELV7Z65AP	IACT
EDETATE SODIUM	MP1J8420LU	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	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 9 · 495 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVENOUS	2.78 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PERIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCUTANEOUS	31.45 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / AURICULAR (OTIC)	0.8 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, COATED / ORAL	0.13 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAVENOUS		400 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, CHEWABLE / ORAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	EMULSION / TOPICAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / RETROBULBAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / SUBCUTANEOUS		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, EXTENDED RELEASE / TRANSDERMAL	0.85 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	0.35 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	CAPSULE / ORAL	1 mg		Exact identifier — unii candidate 12 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
3110ce92-5a57-4dd5-84a0-aebaa5f0678a			b3ea0417-65c2-46ca-9c52-31376dd85637	2012-07-08	Warnings	Exact identifier spl id: 3110ce92-5a57-4dd5-84a0-aebaa5f0678a spl set id: b3ea0417-65c2-46ca-9c52-31376dd85637

Reported adverse events (FAERS/openFDA)#

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