SPF 15 Protective Balm with UVA/UVB Sunscreens

Manufacturer: Laboratoire Dr Renaud inc. | Laboratoire Dr Renaud inc
Effective date: 2011-03-23
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:27:36

Label at a glance#

ProductSPF 15 Protective Balm with UVA/UVB Sunscreens

Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (Octyl Methoxycinnamate) à 7.5 % w/w, Octisalate (Octyl Salicylate) à 3% w/w, Oxybenzone à 3% w/w.

Inactive ingredients

INACTIVE INGREDIENT SECTION

RICINUS COMMUNIS (CASTOR) SEED OIL • LANOLIN OIL • OCTYLDODECANOL • RED PETROLATUM • ISOPROPYL PALMITATE • OZOKERITE • EUPHORBIA CERIFERA (CANDELILLA) WAX / CIRE DE CANDELILLA • BEESWAX / CIRE D’ABEILLE • COPERNICA CERIFERA (CARNAUBA) WAX / CIRE DE CARNAUBA • TOCOPHERYL ACETATE • BISABOLOL • PANTHENOL • TOCOPHEROL • ZEA MAYS (CORN) OIL • VEGETABLE OIL / HUILE VEGETALE • GLYCERYL OLEATE • BETA-CAROTENE • PROPYLENE GLYCOL • TBHQ • CITRIC ACID • ISOPROPYLPARABEN • ISOBUTYLPARABEN • BUTYLPARABEN •

OTC - PURPOSE SECTION

Helps protect from sunburn.Formulated to minimize allergic risks.

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 to 30 minutes before exposure to the sun.Reapply every 2 hours and after swimming perspiring heavily.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartridge label

image of carton label

WARNINGS SECTION

For external use only.Keep out of children. Avoid direct contact with the eyes. Stop use if signs of rash or irritation appear.Children under 6 months, ask doctor.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62499-420-11	2019-10-29	C162847	48780-1	960f7f55-c884-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62499-420-02	SPF 15 Protective Balm with UVA/UVB Sunscreens	3.8 g in 1 CARTRIDGE	STICK	3.8		3
62499-420-11	SPF 15 Protective Balm with UVA/UVB Sunscreens	1 in 1 BOX	STICK	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62499-420	SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS (OCTINOXATE OCTISALATE OXYBENZONE) STICK [LABORATOIRE DR RENAUD INC.]	3	Legacy NDC, 2 package rows	20110330_b8f9e04b-9fe5-478a-8b39-3ff0a03a8797.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	3
ACETATE ION	INACTIVE INGREDIENT	569DQM74SC	3
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	3
BETA CAROTENE	INACTIVE INGREDIENT	01YAE03M7J	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	3
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	3
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	3
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	3
GLYCERYL MONOOLEATE	INACTIVE INGREDIENT	4PC054V79P	3
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	3
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	3
ISOPROPYLPARABEN	INACTIVE INGREDIENT	A6EOX47QK0	3
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	3
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	3
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	3
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
RICINUS COMMUNIS SEED	INACTIVE INGREDIENT	7EK4SFN1TX	3
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	3
T-BUTYLHYDROQUINONE	INACTIVE INGREDIENT	C12674942B	3
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	3

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

SPF 15 Protective Balm with UVA/UVB Sunscreens
Octinoxate Octisalate Oxybenzone
OCTINOXATE
OCTISALATE
OXYBENZONE
RICINUS COMMUNIS SEED
LANOLIN
OCTYLDODECANOL
PETROLATUM
ISOPROPYL PALMITATE
CERESIN
CANDELILLA WAX
YELLOW WAX
CARNAUBA WAX
ACETATE ION
LEVOMENOL
PANTHENOL
ISOPROPYLPARABEN
ISOBUTYLPARABEN
BUTYLPARABEN
ALPHA-TOCOPHEROL
CORN OIL
SUNFLOWER OIL
T-BUTYLHYDROQUINONE
GLYCERYL MONOOLEATE
BETA CAROTENE
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62499-420	62499-420-02, 62499-420-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
RICINUS COMMUNIS SEED	7EK4SFN1TX	IACT
LANOLIN	7EV65EAW6H	IACT
OCTYLDODECANOL	461N1O614Y	IACT
PETROLATUM	4T6H12BN9U	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
CERESIN	Q1LS2UJO3A	IACT
CANDELILLA WAX	WL0328HX19	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
ACETATE ION	569DQM74SC	IACT
LEVOMENOL	24WE03BX2T	IACT
PANTHENOL	WV9CM0O67Z	IACT
ISOPROPYLPARABEN	A6EOX47QK0	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
CORN OIL	8470G57WFM	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
T-BUTYLHYDROQUINONE	C12674942B	IACT
GLYCERYL MONOOLEATE	4PC054V79P	IACT
BETA CAROTENE	01YAE03M7J	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	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 5 · 285 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	TABLET, EXTENDED RELEASE / ORAL	10 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	SPRAY / TOPICAL	0.95 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / VAGINAL	13.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	CAPSULE / ORAL	918 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CREAM, AUGMENTED / TOPICAL	3.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
BETA CAROTENE	BETA CAROTENE	01YAE03M7J	CREAM / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 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
9d8f4ada-04b4-4bcb-a3b3-ab5e5ad0693f			b8f9e04b-9fe5-478a-8b39-3ff0a03a8797	2011-03-23	Warnings	Exact identifier spl id: 9d8f4ada-04b4-4bcb-a3b3-ab5e5ad0693f spl set id: b8f9e04b-9fe5-478a-8b39-3ff0a03a8797

Reported adverse events (FAERS/openFDA)#

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