FDA.reportPublic FDA data

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 149 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen tintedTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3000a0a7-2b51-b832-e063-6294a90a4a082025-12-08WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001028b-bb36-04ec-e063-6294a90a1e492025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001aa3a-cc8b-6ad4-e063-6394a90a223f2025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC300268ff-f9ef-1006-e063-6294a90a5fdf2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC3001ef4f-4cbb-8931-e063-6394a90a5cef2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF40 Non-TintedZINC OXIDEFace 5, LLC300218c9-65cf-d984-e063-6294a90a15172025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC300303e7-ef89-7449-e063-6294a90ac8112025-12-08WarningsExact identifier
application number: M020
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
application number: M020
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
application number: M020
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Non-TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be70d5-aefe-fd6f-e063-6394a90ac4362025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be17ce-c3a7-fd59-e063-6394a90ad11d2025-12-08Exact identifier
application number: M020
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact 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