Homosalate 10 Avobenzone 3% Octocrylene 6%

Product NDC
87170-003
11-digit product format
871700003
Labeler code
87170
Product ID
87170-003_4951b0e0-e27f-b649-e063-6394a90acc11
Type
HUMAN OTC DRUG
Nonproprietary name
SPF 45 Face
Dosage form
LOTION
Route
TOPICAL
Labeler
S&C Hampton Sun LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-15
Substance
OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
6; 10; 3 g/100mL; g/100mL; g/100mL
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
Homosalate 10 Avobenzone 3% Octocrylene 6%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE6 g/100mL
HOMOSALATE10 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e49808c9-5025-4965-8679-7fe824cf6907Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87170-003-01Homosalate 10 Avobenzone 3% Octocrylene 6%20 mL in 1 TUBELOTION203
87170-003-02Homosalate 10 Avobenzone 3% Octocrylene 6%59 mL in 1 TUBELOTION593

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
87170-003-018717000030120 mL in 1 TUBE (87170-003-01) 20 ml2024-01-15NoNoCurrent
87170-003-028717000030259 mL in 1 TUBE (87170-003-02) 59 ml2024-01-15NoNoCurrent