FDA.reportPublic FDA data

Homosalate, Octisalate, Zinc oxide

Product NDC
76162-957
11-digit product format
761620957
Labeler code
76162
Product ID
76162-957_4ab9f7f0-adbb-d8a3-e063-6394a90ad8d0
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-22
Substance
HOMOSALATE; ZINC OXIDE; OCTISALATE
Active strength
100; 63; 50 mg/mL; mg/mL; mg/mL
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, Octisalate, Zinc oxide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
ZINC OXIDE63 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
SOI2LOH54ZInternal 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
48fb9a3c-c058-ce71-e063-6294a90aaf1eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-957-21Homosalate, Octisalate, Zinc oxide89 mL in 1 BOTTLE, PLASTICLOTION892
76162-957-21Homosalate, Octisalate, Zinc oxide1 in 1 CARTONLOTION12

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 116 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c043e0-fd6c-5f7a-e063-6294a90a88992025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
application number: M020
Daily Protect Mineral SunscreenZINC OXIDESARAH'S4617beb7-381e-8994-e063-6394a90a14b52025-12-16WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENTENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDEShiseido Americas Corporation8db9f5e0-a8d6-4872-b4c6-cb92c43d25c22025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation18ed9b7f-bdbe-45d7-a38c-6d065080ae992025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE FOR BODY NENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationa2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c2025-12-16WarningsExact identifier
application number: M020
b.tan Beach Please SPF 7AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbdc07d83-a34f-5262-e053-2995a90acfc32025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S461910bd-1f74-f99e-e063-6394a90ae30e2025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S4619b08f-3e63-25aa-e063-6294a90a78d72025-12-16WarningsExact identifier
application number: M020
megALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48Meg Cosmetics Inc4526bacf-6451-b297-e063-6294a90af71a2025-12-16WarningsExact identifier
application number: M020
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
application number: M020
Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32ZINC OXIDEOnekind.25c11197f4-cee0-04b3-e053-2995a90a1ba82025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Medium DeepZINC OXIDECrunchi, LLC.69618265-2ebb-4cdc-a28f-e36c07fe5b8f2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 MediumZINC OXIDECrunchi, LLC.23248bc3-1b82-443a-b38a-df7f0efb5d2a2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 LightZINC OXIDECrunchi, LLC.cf4039f5-00ee-4227-a3dc-61995c8001352025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Body Sunscreen SPF 30ZINC OXIDECrunchi, LLC.227f5a41-8c3c-492d-947f-e2b046208bca2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Light MediumZINC OXIDECrunchi, LLC.5b3f2766-065b-4817-a5ff-bd1c7882bfc92025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Daily Facial Sunscreen SPF 30ZINC OXIDECruchi, LLC.4f3bcfa0-e43e-4284-afaa-6488ddd749f02025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76162-957-21761620957211 BOTTLE, PLASTIC in 1 CARTON (76162-957-21) / 89 mL in 1 BOTTLE, PLASTIC2026-01-22NoNoCurrent