FDA.reportPublic FDA data

Hawaiian Tropic Lip Balm Sunscreen SPF 30

Product NDC
63354-520
11-digit product format
633540520
Labeler code
63354
Product ID
63354-520_47ba86ad-2409-e733-e063-6394a90a24e3
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,OCTISALATE,OCTOCRYLENE
Dosage form
STICK
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-01
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 3 g/100g; g/100g; g/100g
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
Hawaiian Tropic Lip Balm Sunscreen SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100g
OCTISALATE5 g/100g
AVOBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal 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
c7b71be3-f906-bd09-e053-2995a90adc61Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-520-61Hawaiian Tropic Lip Balm Sunscreen SPF 304.25 g in 1 CYLINDERSTICK4.254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-520HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30 (AVOBENZONE,OCTISALATE,OCTOCRYLENE) STICK [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 1 package rows20231025_c7b71be3-f906-bd09-e053-2995a90adc61.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 102 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen for the faceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bcab9-9b75-a17c-e063-6294a90aafd92025-12-23WarningsExact identifier
application number: M020
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAYAVOBENZONE, OCTINOXATE, OCTISALATEKOS America, Inc.81352963-36ec-4099-af51-3498d89f30772025-12-23WarningsExact identifier
application number: M020
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen dropsZINC OXIDE, OCTINOXATELongway Technology(Guangzhou)Co.,Ltd.451b4d37-99e2-8e4f-e063-6294a90a51bb2025-12-23WarningsExact identifier
application number: M020
Reclaim Revolutionary Anti-Aging Day SPF15OCTINOXATE, OCTISALATE, AND OXYBENZONEGuthy-Renker LLC4b735c91-f650-4531-8744-c211d57a3e282025-12-23WarningsExact identifier
application number: M020
SCINIC ENJOY SUPER MILD SUN ESSENCE EXAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEELEVEN STREET35272744-8253-046c-e063-6394a90aabc22025-12-22WarningsExact identifier
application number: M020
TINTED FACIAL SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1259035e-9196-97de-e063-6394a90a9dec2025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP BALMETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.0f8e08bf-4b14-bdad-e063-6394a90a34e12025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.1c32b019-a038-eb61-e063-6394a90a45f22025-12-22WarningsExact identifier
application number: M020
SPF 50 MINERAL SUNSCREEN LIPZINC OXIDE , TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1c6f0964-9bee-1c06-e063-6294a90ac2a42025-12-22WarningsExact identifier
application number: M020
Absolut Skin SPF 50 Moisturizing SunscreenETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.3264543c-e8f5-da9a-e063-6394a90ac8c62025-12-22WarningsExact identifier
application number: M020
Firmarine Moisturizer SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATEErno Laszlo, Inc.073f8b95-6f46-4341-817f-22f5b4f325422025-12-22WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.468c90d7-3b9e-1641-e063-6394a90a928c2025-12-22WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3e65ec1a-0ed9-433d-8da9-a6cb618299112025-12-22WarningsExact identifier
application number: M020
Sun Shades Sunscreen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMelaleuca Inc.1f982f03-9542-29f9-e063-6294a90a959c2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.ca99b8c4-6778-43dc-bdd5-ca4a470860a02025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f810843b-5a4d-6cbc-e053-6294a90ac9e32025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.7a5644b9-4368-4e9a-aa22-b3307acf43cc2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT CERAMIDE SPF-30ZINC OXIDESOLARA SUNCARE, INC.cbf9c715-2d45-4c1b-b58f-42795722821c2025-12-22WarningsExact identifier
application number: M020
SPF 50 Baby Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc4690d89b-ae61-2ed5-e063-6294a90a743f2025-12-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-520-61633540520614.25 g in 1 CYLINDER (63354-520-61) 4.25 g2021-09-010000-00-00NoNoCurrent