PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30

Product NDC
49404-157
11-digit product format
494040157
Labeler code
49404
Product ID
49404-157_51291c13-9634-7263-e063-6294a90a4d39
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Have & Be Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-09
Substance
OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE
Active strength
68; 50; 45; 48 mg/mL; 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
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE68 mg/mL
ZINC OXIDE50 mg/mL
OCTISALATE45 mg/mL
TITANIUM DIOXIDE48 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a7e868d-6310-6ee4-e063-6394a90aebceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49404-157-01PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 301 in 1 CARTONLOTION12
49404-157-01PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 3040 mL in 1 TUBELOTION402
49404-157-99PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 301 mL in 1 PACKETLOTION12

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 27 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSICZINC OXIDEColorescienced46533c7-c92d-d161-e053-2995a90a8e4b2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield GlowZINC OXIDEColoresciencecdb5397a-c463-4b41-e053-2a95a90a9e032026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield MatteZINC OXIDEColoresciencecd879b3e-16a2-2cca-e053-2a95a90a14f82026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Body ShieldZINC OXIDEColoresciencecdb413bb-58ab-1e0f-e053-2995a90aab0f2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield FlexZINC OXIDEColoresciencecdb55347-aedd-4de6-e053-2a95a90afec72026-05-21WarningsExact identifier
application number: M020
Odacite Flex Perfecting Mineral Drops Tinted SunscreenZINC OXIDEOdacite52560b2d-ebb5-5d96-e063-6294a90a15ee2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield BronzeZINC OXIDEColoresciencecdb577e4-5c80-7eac-e053-2a95a90a105b2026-05-21WarningsExact identifier
application number: M020
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52564e2f-983d-89ba-e063-6394a90ab4242026-05-21WarningsExact identifier
application number: M020
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
application number: M020
Agent Natuer holi (sun) dewy tinted skin dropsZINC OXIDEAgent Natuer043734b8-9aee-cdf1-e063-6294a90aec602026-05-21WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09bb5f97-f4db-a2d4-e063-6394a90a84fd2026-05-21WarningsExact identifier
application number: M020
Skin Metal Green StealthZINC OXIDESkin Metal47f562cc-48cc-97f9-e063-6294a90a72162026-05-21WarningsExact identifier
application number: M020
Blume Sunburst SunscreenZINC OXIDEBlume21ef2c6b-8ae7-8bcf-e063-6294a90ae9e12026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST13 KAMARI)ZINC OXIDEIlia, Inc.b595ca2c-177e-b357-e053-2995a90a54f62026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST6 ORA)ZINC OXIDEIlia, Inc.b59537d4-e1d8-53e4-e053-2995a90a2ce32026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST16 PAVONES)ZINC OXIDEIlia, Inc.b595f1e9-36f7-615d-e053-2a95a90abb1c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO)ZINC OXIDEIlia, Inc.b97dc2ac-dd6d-403d-e053-2995a90a0d9c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA)ZINC OXIDEIlia, Inc.b595db16-7969-726f-e053-2995a90ab7832026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11 MATIRA)ZINC OXIDEIlia, Inc.b595b5f0-dd3d-79ef-e053-2a95a90ad9fb2026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49404-157-01494040157011 TUBE in 1 CARTON (49404-157-01) / 40 mL in 1 TUBE1 tube2026-02-09NoNoCurrent
49404-157-99494040157991 mL in 1 PACKET (49404-157-99) 1 ml2026-02-09YesNoCurrent