FDA.reportPublic FDA data

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15

Product NDC
84066-103
11-digit product format
840660103
Labeler code
84066
Product ID
84066-103_46871df7-0e77-a3c4-e063-6394a90a82c5
Type
HUMAN OTC DRUG
Nonproprietary name
Ethylhexyl Methoxycinnamate, Octocrylene
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Tata Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-02
Substance
OCTINOXATE; OCTOCRYLENE
Active strength
7.5; 5 mg/100mL; mg/100mL
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
SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 mg/100mL
OCTOCRYLENE5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c32b019-a038-eb61-e063-6394a90a45f2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84066-103-01SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 1510 mL in 1 TUBEGEL104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84066-103SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 (ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE) GEL [GUANGZHOU TATA BIOTECHNOLOGY CO., LTD.]2Current NDC, 1 package rows20240723_1c32b019-a038-eb61-e063-6394a90a45f2.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 70 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields7fe05ef6-dd5f-4f25-bbf7-24f9396427072026-01-23WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen NacreCEILE SPF 30 PRIME PROTECT RADIATE NACRELE COSMETICS INC4915de09-3a2c-cb75-e063-6394a90a6a572026-01-23WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEAustralian Gold248d761c-2120-4019-9463-9952bc367e732026-01-23WarningsExact identifier
application number: M020
SOLBAR THIRTYSUNSCREENPerson and Covey48ed3be8-d146-ec2c-e063-6394a90a6c4d2026-01-22WarningsExact identifier
application number: M020
MISSHA ALL AROUND ESSENCE SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f557b5-a844-8c94-e063-6394a90af2202026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f5e9ab-38e0-f12c-e063-6294a90aab8b2026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREENZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDEAble C&C Co., Ltd.48f6361d-d738-62df-e063-6294a90aaac52026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 35 AVOSUNSCREENPerson and Covey4a5692d5-0835-d18f-e063-6394a90a29292026-01-22WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF15OCTINOXATE, AVOBENZONE, OCTISALATEDongguan Taimeng Accessories Co., Ltd.48f70710-7960-5fa5-e063-6394a90a4ce62026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 ZINCSUNSCREENPerson and Covey48fc01dd-0be4-5c63-e063-6294a90a23622026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 SHIELDSUNSCREENPerson and Covey48fcd463-8ce4-1e78-e063-6394a90a98e72026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 50 FIFTYSUNSCREENPerson and Covey48fef521-1b24-d0d5-e063-6394a90ac7b12026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7456f4bb-d0ec-439d-b807-d00b4c01c1112026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.2dd51960-515f-4502-b261-5e5d5f57e0912026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5b835716-af13-4e23-bdae-d391864acb6f2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa258570-ee21-423d-bad6-010d14792a862026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa84c1b5-a9b6-408e-b9fd-0dadebaf374e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6b7a016c-c3b1-4f90-80c9-fe47c52916492026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5d029d93-7f3d-4624-bcd7-40df9230414e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f724d68-3c6e-4b95-894e-78b2da220a302026-01-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84066-103-018406601030110 mL in 1 TUBE (84066-103-01) 10 ml2024-07-02NoNoCurrent