DERMA BRITE

Manufacturer: PHARMAGEL INTERNATIONAL INC
Effective date: 2024-08-13
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:17:14

Label at a glance#

ProductDERMA BRITE SPF 35

Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE

Label structure8 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 • reapply: • after 40 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 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...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 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 on damaged or broken skin.

When using product keep out of eyes. Rinse with warm water to remove.

Stop use and ask doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure

• reapply:
• after 40 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 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: Ask a doctor

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

water (aqua, eau), citrus unshiu peel extract, ethylhexyl palmitate, propylene glycol, glyceryl stearate, peg-100 stearate, cetearyl alcohol, dimethicone, palmitic acid, phenoxyethanol, stearic acid, myristyl myristate, acrylates/c10-30 alkyl acrylate crosspolymer, caprylyl glycol, hydroxyethylcellulose, triethanolamine, glycerin, ethylhexylglycerin, allantoin, hexylene glycol, myristyl laurate, panthenol, tetrasodium edta, fragrance (parfum), glycolic acid, butylene glycol, morus alba leaf extract, myristic acid, kojic acid, magnesium ascorbyl phosphate, niacin, phyllanthus emblica fruit exract, undecylenoyl phenylalanine, glycyrrhiza glabra (licorice) root extract, arachidic acid, camellia sinensis (green tea) leaf extract, bht, potassium sorbate, cyperus rotundus root extract, limonene, sodium citrate, linalool, citric acid, citronellol, sodium benzoate, lactic acid, yellow 6 (ci 15985), biotin, red 40 (ci 16035), undecylenic acid, chlorphenesin, benzoic acid, sorbic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERB_1_RL-1_box_final.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67879-308-11	DERMA BRITESPF 35	56 g in 1 JAR	CREAM	56		6
67879-308-51	DERMA BRITESPF 35	1 in 1 BOX	CREAM	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67879-308	DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]	6	Current NDC, Legacy NDC, 2 package rows	20240815_fe10912e-00e3-406c-a80c-d9c991dc9f8b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
.BETA.-CITRONELLOL, (+/-)-	INACTIVE INGREDIENT	565OK72VNF	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	1
ARACHIDIC ACID	INACTIVE INGREDIENT	PQB8MJD4RB	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BIOTIN	INACTIVE INGREDIENT	6SO6U10H04	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	1
CYPERUS ROTUNDUS ROOT	INACTIVE INGREDIENT	4B51SRR959	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	1
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
GLYCOLIC ACID	INACTIVE INGREDIENT	0WT12SX38S	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	1
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	1
KOJIC ACID	INACTIVE INGREDIENT	6K23F1TT52	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	1
LIMONENE, (+)-	INACTIVE INGREDIENT	GFD7C86Q1W	1
LINALOOL, (+)-	INACTIVE INGREDIENT	F4VNO44C09	1
MAGNESIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	0R822556M5	1
MANDARIN OIL	INACTIVE INGREDIENT	NJO720F72R	1
MORUS ALBA LEAF	INACTIVE INGREDIENT	M8YIA49Q2P	1
MYRISTIC ACID	INACTIVE INGREDIENT	0I3V7S25AW	1
MYRISTYL LAURATE	INACTIVE INGREDIENT	58U0NZN2BT	1
MYRISTYL MYRISTATE	INACTIVE INGREDIENT	4042ZC00DY	1
NIACIN	INACTIVE INGREDIENT	2679MF687A	1
PALMITIC ACID	INACTIVE INGREDIENT	2V16EO95H1	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
PHYLLANTHUS EMBLICA FRUIT	INACTIVE INGREDIENT	YLX4CW2576	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
UNDECYLENIC ACID	INACTIVE INGREDIENT	K3D86KJ24N	1
UNDECYLENOYL PHENYLALANINE	INACTIVE INGREDIENT	271P08C6OD	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 2 · 57 matching rows.

DERMA BRITE SPF 35
OCTINOXATE, OCTISALATE, OXYBENZONE
WATER
TANGERINE PEEL
ETHYLHEXYL PALMITATE
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
CETOSTEARYL ALCOHOL
DIMETHICONE
PALMITIC ACID
PHENOXYETHANOL
STEARIC ACID
MYRISTYL MYRISTATE
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
CAPRYLYL GLYCOL
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
TROLAMINE
GLYCERIN
ETHYLHEXYLGLYCERIN
ALLANTOIN
HEXYLENE GLYCOL
MYRISTYL LAURATE
PANTHENOL
EDETATE SODIUM
GLYCOLIC ACID
BUTYLENE GLYCOL
MORUS ALBA LEAF
MYRISTIC ACID
KOJIC ACID
MAGNESIUM ASCORBYL PHOSPHATE
NIACIN
PHYLLANTHUS EMBLICA FRUIT
UNDECYLENOYL PHENYLALANINE
GLYCYRRHIZA GLABRA
ARACHIDIC ACID
GREEN TEA LEAF
BUTYLATED HYDROXYTOLUENE
POTASSIUM SORBATE
CYPERUS ROTUNDUS ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67879-308	67879-308-11, 67879-308-51

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
TANGERINE PEEL	JU3D414057	IACT
ETHYLHEXYL PALMITATE	2865993309	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
DIMETHICONE	92RU3N3Y1O	IACT
PALMITIC ACID	2V16EO95H1	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MYRISTYL MYRISTATE	4042ZC00DY	IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	IACT
TROLAMINE	9O3K93S3TK	IACT
GLYCERIN	PDC6A3C0OX	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
ALLANTOIN	344S277G0Z	IACT
HEXYLENE GLYCOL	KEH0A3F75J	IACT
MYRISTYL LAURATE	58U0NZN2BT	IACT
PANTHENOL	WV9CM0O67Z	IACT
EDETATE SODIUM	MP1J8420LU	IACT
GLYCOLIC ACID	0WT12SX38S	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
MORUS ALBA LEAF	M8YIA49Q2P	IACT
MYRISTIC ACID	0I3V7S25AW	IACT
KOJIC ACID	6K23F1TT52	IACT
MAGNESIUM ASCORBYL PHOSPHATE	0R822556M5	IACT
NIACIN	2679MF687A	IACT
PHYLLANTHUS EMBLICA FRUIT	YLX4CW2576	IACT
UNDECYLENOYL PHENYLALANINE	271P08C6OD	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
ARACHIDIC ACID	PQB8MJD4RB	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
CYPERUS ROTUNDUS ROOT	4B51SRR959	IACT
LIMONENE, (+)-	GFD7C86Q1W	IACT
SODIUM CITRATE	1Q73Q2JULR	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 2 · 114 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LOTION / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii+route 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
PALMITIC ACID	PALMITIC ACID	2V16EO95H1	TABLET / ORAL	6 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CREAM / TOPICAL		1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
UNDECYLENIC ACID	UNDECYLENIC ACID	K3D86KJ24N	SPRAY / TOPICAL		22 mg	Exact identifier — unii+route 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii+route 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CREAM / TOPICAL		1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	SOLUTION / TOPICAL	0.6 %w/v		Exact identifier — unii+route 3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	LOTION / TOPICAL		21 mg	Exact identifier — unii+route 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii+route 3 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	GEL / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
HEXYLENE GLYCOL	HEXYLENE GLYCOL	KEH0A3F75J	CREAM / TOPICAL		385 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii+route 6 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	LOTION / TOPICAL		21 mg	Exact identifier — unii+route 3 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	SOLUTION / TOPICAL	0.6 %w/v		Exact identifier — unii+route 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
LIMONENE, (+)-	LIMONENE, (+)-	GFD7C86Q1W	GEL / TOPICAL		10 mg	Exact identifier — unii+route 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LOTION / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
UNDECYLENIC ACID	UNDECYLENIC ACID	K3D86KJ24N	SPRAY / TOPICAL		22 mg	Exact identifier — unii+route 3 equally ranked IID candidates
LIMONENE, (+)-	LIMONENE, (+)-	GFD7C86Q1W	GEL / TOPICAL		10 mg	Exact identifier — unii+route 6 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	GEL / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	LOTION / TOPICAL		21 mg	Exact identifier — unii+route 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
PALMITIC ACID	PALMITIC ACID	2V16EO95H1	TABLET / ORAL	6 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
MYRISTIC ACID	MYRISTIC ACID	0I3V7S25AW	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CREAM / TOPICAL		1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
PALMITIC ACID	PALMITIC ACID	2V16EO95H1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
LIMONENE, (+)-	LIMONENE, (+)-	GFD7C86Q1W	GEL / TOPICAL		10 mg	Exact identifier — unii+route 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii+route 6 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
DERMA BRITE SPF 35	OCTINOXATE, OCTISALATE, OXYBENZONE	PHARMAGEL INTERNATIONAL INC	fe10912e-00e3-406c-a80c-d9c991dc9f8b	2024-08-13	Warnings	Exact identifier ndc (package): 67879-308-11 ndc (package): 67879-308-51 ndc (product): 67879-308 ndc11 (package): 67879030851 ndc11 (package): 67879030811 spl id: 1f945a92-b7d2-59f2-e063-6394a90a2483 spl set id: fe10912e-00e3-406c-a80c-d9c991dc9f8b

Reported adverse events (FAERS/openFDA)#

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