AVOBENZONE, HOMOSALATE, OCTISALATE

Product NDC
76162-941
11-digit product format
761620941
Labeler code
76162
Product ID
76162-941_58636012-7e2a-7206-e063-6394a90a83e9
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-06
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 100; 50 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
AVOBENZONE, HOMOSALATE, OCTISALATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE100 mg/g
OCTISALATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58636012-7e29-7206-e063-6394a90a83e9Available on FDA.report

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 333 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex 10 Count Variety Pack SPF 15 SunscreenOCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.bacc60ec-0b6a-4ba2-b246-a59694f06b772023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Tropical Colada SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.d5538bd0-4bab-4401-a0b8-632809a1e04c2023-10-25WarningsExact identifier
application number: M020
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.5720bd35-de4a-4db4-a4df-0fbc59719bfd2023-10-25WarningsExact identifier
application number: M020
Carmex Classic Lip Balm Medicated SPF 15OCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.ca20b2dc-97e5-461a-94c8-5c109cd152852023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Orange Dream SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.aeea02a0-233e-43b6-b1b8-95ae64b7fa002023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.41e4fca8-22c0-4a8a-95d3-e4aad559548a2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Honey Dew Melon SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.2f721ae7-1922-4463-bb5f-64699907a6692023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.6ef888a3-77c0-498f-92c4-d482cf96ef462023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.4e868b1a-7c47-45de-83cd-0bd5fbb05a272023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.a298815d-9f1f-419d-9dad-6bbfcddc7a482023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb6086c1-f775-70ed-e053-2995a90a531e2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Sweets SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb62d499-1d78-1324-e053-2a95a90abe3c2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.f3eb98dc-9ab3-4123-9490-a1bbf9b3259a2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb132025-658f-d6f8-e053-2995a90a089b2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.2caa7b23-2adb-4953-b044-1b1ad9a5798b2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bae876db-e410-64f6-e053-2995a90a9ebe2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb029c71-4f07-2754-e053-2995a90a7c782023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Wintergreen and Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb28c2e7-4189-fc11-e053-2995a90a92ad2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Favorites SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb611c57-a8ac-0c23-e053-2995a90a5b402023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Holiday SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bbf118c0-7cd5-5a82-e053-2a95a90ac8c82023-10-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-941-1476162094114156 g in 1 CAN (76162-941-14) 156 g2026-08-06NoNoCurrent