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 128 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Mineral ProtectionZINC OXIDECharisma Skin352dc69b-86d0-aa15-e063-6294a90a5e4c2025-12-12Exact identifier
application number: M020
Ultra Sheer SunscreenZINC OXIDESKINBAR MD LLC35810a90-e2ca-b80b-e063-6294a90a14f02025-12-12Exact identifier
application number: M020
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3531d609-a0d8-cb59-e063-6394a90a4bea2025-12-12Exact identifier
application number: M020
Non-Tinted Zinc Body And Face SPF40ZINC OXIDERSL89 LLC3532102c-8ded-1e78-e063-6294a90ae2242025-12-12Exact identifier
application number: M020
Non-Tinted Zinc Body And Face SPF40ZINC OXIDERSL89 LLC35330a82-dc6b-49af-e063-6394a90af9ea2025-12-12Exact identifier
application number: M020
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC353257db-6c30-4a03-e063-6294a90ae45d2025-12-12Exact identifier
application number: M020
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3532a6a2-dbb5-8111-e063-6294a90aeaeb2025-12-12Exact identifier
application number: M020
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC35334c75-b3fd-37fa-e063-6294a90ab3b02025-12-12Exact identifier
application number: M020
Age Defying SunscreenZINC OXIDEGINAMARIE Products35835565-f10b-e8e7-e063-6394a90ab2d32025-12-12Exact identifier
application number: M020
Tinted Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC35338026-525a-d8b3-e063-6394a90a98f52025-12-12Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3541971e-3664-a9f5-e063-6294a90ac2d22025-12-12Exact identifier
application number: M020
Age Defying SunscreenZINC OXIDEGINAMARIE Products35837cf7-91e5-f9ec-e063-6394a90aa91e2025-12-12Exact identifier
application number: M020
Mineral Sunscreen Face plus BodyZINC OXIDEKS Esthetics, LLC390a4d8d-b47f-0d9a-e063-6394a90a9b532025-12-12Exact identifier
application number: M020
Mineral Sunscreen Tinted Zinc OxideZINC OXIDEKS Esthetics, LLC3909e657-97a5-dd3c-e063-6394a90a10eb2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS366149e2-b03c-e798-e063-6394a90a6a1d2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS3661251d-b907-8df6-e063-6294a90a1c732025-12-12Exact identifier
application number: M020
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact 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