Safe Sea SPF 40

Product NDC
65435-0300
11-digit product format
654350300
Labeler code
65435
Product ID
65435-0300_4584a34d-7130-aa5e-e063-6394a90ae4f2
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane
Dosage form
LIQUID
Route
TOPICAL
Labeler
NIDARIA TECHNOLOGY LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
100; 100; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
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
Safe Sea SPF 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE100 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal 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
c900b88b-1de1-4df9-af84-d9001e1d4764Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65435-0300-1Safe Sea SPF 40118 mL in 1 BOTTLELIQUID11810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65435-0300SAFE SEA SPF 40 (OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE) LIQUID [NIDARIA TECHNOLOGY LTD]8Current NDC, Legacy NDC, 1 package rows20241123_c900b88b-1de1-4df9-af84-d9001e1d4764.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 13 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRMZINC OXIDECOSMAX USA, CORP5647ae2c-bcba-63c0-e063-6394a90ad5bc2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRMZINC OXIDECOSMAX USA, CORP56478f3d-f25c-bef7-e063-6294a90ade092026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOLZINC OXIDECOSMAX USA, CORP564796f8-072f-61f2-e063-6394a90ab3942026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOLZINC OXIDECOSMAX USA, CORP5647e63c-a695-1b40-e063-6394a90a57672026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRALZINC OXIDECOSMAX USA, CORP5647d0f1-945f-b0b7-e063-6294a90aafe22026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset SandsZINC OXIDECOSMAX USA, CORP5648da76-5a67-605a-e063-6294a90a4e3b2026-07-10WarningsExact identifier
application number: M020
Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5648d637-9743-97a7-e063-6294a90ad8a12026-07-10WarningsExact identifier
application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla CloudZINC OXIDECOSMAX USA, CORP5648c90b-b814-c16e-e063-6394a90a3e1f2026-07-10WarningsExact identifier
application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Berry BalmyZINC OXIDECOSMAX USA, CORP56490982-200d-e3a7-e063-6394a90a72a42026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Warm SiennaZINC OXIDECOSMAX USA, CORP56491794-712d-1306-e063-6394a90a47072026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Bright BerryZINC OXIDECOSMAX USA, CORP56491833-5053-c85e-e063-6294a90ac4f52026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Nude RoseZINC OXIDECOSMAX USA, CORP56493964-1d5b-2fc7-e063-6394a90a74922026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Soft PetalZINC OXIDECOSMAX USA, CORP5649df7b-9d2c-d8eb-e063-6394a90acf992026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Nude GlowZINC OXIDECOSMAX USA, CORP564a6566-442c-b933-e063-6294a90a6f9b2026-07-10WarningsExact identifier
application number: M020
SOFIE PAVITT FACE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA., CORP564ae5d2-1504-9623-e063-6394a90a2fa52026-07-10WarningsExact identifier
application number: M020
IDEALOVE HYDROGLOW DAILY SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORP564b284c-3248-c6c0-e063-6394a90a11032026-07-10WarningsExact identifier
application number: M020
SOFIE PAVITT FACE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA., CORP564b1ed2-aa98-a334-e063-6294a90a169b2026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOLDEN HOURZINC OXIDECOSMAX USA, CORP564b559e-6fe8-e98e-e063-6294a90a8f0e2026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 BLISS ON THE BEACHZINC OXIDECOSMAX USA, CORP564b63f2-701e-f5bd-e063-6394a90af7972026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOING COCONUTSZINC OXIDECOSMAX USA, CORP564b5ab3-0a7c-f663-e063-6394a90a0c3d2026-07-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65435-0300-165435030001118 mL in 1 BOTTLE (65435-0300-1) 118 ml2021-01-010000-00-00NoNoCurrent