DERMA BRITE

Product NDC
67879-308
11-digit product format
678790308
Labeler code
67879
Product ID
67879-308_1f945a92-b7d2-59f2-e063-6394a90a2483
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
PHARMAGEL INTERNATIONAL INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-18
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
7.5; 5; 3 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
DERMA BRITE
Brand name suffix
SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100g
OCTISALATE5 g/100g
OXYBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe10912e-00e3-406c-a80c-d9c991dc9f8bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67879-308-11DERMA BRITESPF 3556 g in 1 JARCREAM566
67879-308-51DERMA BRITESPF 351 in 1 BOXCREAM16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
.BETA.-CITRONELLOL, (+/-)-INACTIVE INGREDIENT565OK72VNFDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
ALLANTOININACTIVE INGREDIENT344S277G0ZDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
ARACHIDIC ACIDINACTIVE INGREDIENTPQB8MJD4RBDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
BIOTININACTIVE INGREDIENT6SO6U10H04DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RADERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
CYPERUS ROTUNDUS ROOTINACTIVE INGREDIENT4B51SRR959DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
KOJIC ACIDINACTIVE INGREDIENT6K23F1TT52DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1WDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
LINALOOL, (+)-INACTIVE INGREDIENTF4VNO44C09DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
MANDARIN OILINACTIVE INGREDIENTNJO720F72RDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
MORUS ALBA LEAFINACTIVE INGREDIENTM8YIA49Q2PDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
MYRISTIC ACIDINACTIVE INGREDIENT0I3V7S25AWDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
MYRISTYL LAURATEINACTIVE INGREDIENT58U0NZN2BTDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
NIACININACTIVE INGREDIENT2679MF687ADERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
PHYLLANTHUS EMBLICA FRUITINACTIVE INGREDIENTYLX4CW2576DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
UNDECYLENIC ACIDINACTIVE INGREDIENTK3D86KJ24NDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
UNDECYLENOYL PHENYLALANINEINACTIVE INGREDIENT271P08C6ODDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67879-308DERMA BRITE SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC]6Current NDC, Legacy NDC, 2 package rows20240815_fe10912e-00e3-406c-a80c-d9c991dc9f8b.zip

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 68 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Centellian24 Madeca Derma Shield Vital Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e11009-ffcb-dd59-e063-6294a90add222026-01-27WarningsExact identifier
application number: M020
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M020
ONSART Mineral Sunscreen SPF 50ZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.495e3266-a59f-42f7-e063-6394a90adfa32026-01-27WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC54868d6f-ae4c-476d-8c77-c4a72b13d2ea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCdd036e0c-0c27-42b3-9d2c-33839a8631f92026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea23616f-1d59-4e32-88bb-d035af7277282026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic TwistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC21b6239b-26d0-4b6b-8aee-fe1f20d8aaea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC483b6873-fe58-4a38-bf82-df116617c5f02026-01-27WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50 MINERALS&C Hampton Sun4960930e-a1bf-d850-e063-6294a90a40842026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
application number: M020
Golden Glow SHIMMER MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD4963e513-d1fc-4b0e-e063-6394a90a7ddf2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD496ba4c4-6577-88ff-e063-6294a90a09952026-01-27WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.b442530f-cae3-418b-9675-c188796538262026-01-27WarningsExact identifier
application number: M020
EltaMD UV Clear Blemish-Prone and Oil BalancingOCTINOXATE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6337b9e3-2524-4292-8fc8-1f6aad6cfe052026-01-27WarningsExact identifier
application number: M020
SPF Ginger Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESPF GINGER LLCf303ad78-5fa3-40d1-9b1c-53ae1ca73aed2026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC8506049f-cb43-4d1d-885b-c6d3a99bbba32026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC144178e7-2df9-49c3-9667-43986cee89c42026-01-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67879-308-116787903081156 g in 1 JAR56 gHistorical
67879-308-51678790308511 JAR in 1 BOX (67879-308-51) / 56 g in 1 JAR (67879-308-11) 1 jar2016-06-130000-00-00NoNoCurrent