Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50

Product NDC: 84448-801
11-digit product format: 844480801
Labeler code: 84448
Product ID: 84448-801_44952d01-7f39-0a9c-e063-6394a90a2018
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: THG Beauty USA LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-01-01
Substance: ZINC OXIDE; TITANIUM DIOXIDE
Active strength: 5.74; 5.1359 g/100mL; g/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: Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	5.74 g/100mL
TITANIUM DIOXIDE	5.1359 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
44952d01-7f38-0a9c-e063-6394a90a2018	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84448-801-12	Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50	120 mL in 1 TUBE	CREAM	120	1
84448-801-12	Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50	1 in 1 CARTON	CREAM	1	1
84448-801-30	Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50	30 mL in 1 TUBE	CREAM	30	1
84448-801-30	Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50	1 in 1 CARTON	CREAM	1	1
84448-801-60	Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50	1 in 1 CARTON	CREAM	1	1
84448-801-60	Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50	60 mL in 1 TUBE	CREAM	60	1

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 79 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50	ZINC OXIDE	Noble Panacea Labs, Inc.	aed57f81-4b7d-42dc-993e-6bb10f93b02a	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	0d9f132c-7630-4261-a0f8-fc7a4377731f	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	f292da7d-ffd2-41c3-9a64-619aab19ff18	2026-01-15	Warnings	Exact identifier application number: M020
Multivit Sun Protector	TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	abdb560d-29be-41dc-ad23-54ea571acb14	2026-01-15	Warnings	Exact identifier application number: M020
BeautyBarrier	ZINC OXIDE	NAKED SUNDAYS PTY LTD	45740afa-230d-4dd5-e063-6394a90a102f	2026-01-15	Warnings	Exact identifier application number: M020
Glow This Way	OCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATE	Koco Life LLC	4619cf96-987a-3e88-e063-6294a90afbe9	2026-01-15	Warnings	Exact identifier application number: M020
Reef safe lip balm 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	486930f2-026b-14b4-e063-6394a90aa031	2026-01-15	Warnings	Exact identifier application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	CLINIQUE LABORATORIES LLC	316bf6f8-7d30-2560-e063-6294a90afb8a	2026-01-15	Warnings	Exact identifier application number: M020
Wellcare Sunstick Lip Balm	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE	BAMKO, LLC	ef977575-7ef0-fc09-e053-2a95a90a8993	2026-01-15	Warnings	Exact identifier application number: M020
Bali Body Sheer Glow Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	4872793c-a7c0-1b65-e063-6394a90a8b3a	2026-01-15	Warnings	Exact identifier application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Volition Beauty	2631de4b-66e3-0547-e063-6394a90a822c	2026-01-15	Warnings	Exact identifier application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30	ZINC OXIDE	SKINN COSMETICS, LLC	350ed168-ab3b-f314-e063-6394a90a8bbf	2026-01-15	Warnings	Exact identifier application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	StriVectin Operating Company, Inc.	4873a262-a19b-555e-e063-6394a90a182a	2026-01-15	Warnings	Exact identifier application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	e843bb6b-257f-4425-95bc-41774e032a09	2026-01-15	Warnings	Exact identifier application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	1e18f1dd-a4e4-455a-9699-5634b9559678	2026-01-15	Warnings	Exact identifier application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	485c345f-0928-fa1a-e063-6294a90aa856	2026-01-14	Warnings	Exact identifier application number: M020
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30	ZINC OXIDE	LABORATOIRES DRUIDE INC	19af4441-31b2-72db-e063-6394a90a813c	2026-01-14	Warnings	Exact identifier application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30	ZINC OXIDE	Sqween LLC	9c3cf35b-4bde-46e3-8abd-5f4d1ad6e486	2026-01-14	Warnings	Exact identifier application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30	TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES DRUIDE INC	0799ac38-9a41-6579-e063-6394a90ac4b6	2026-01-14	Warnings	Exact identifier application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30	ZINC OXIDE	LABORATOIRES DRUIDE INC	0b412e24-baf6-e68e-e063-6394a90a5f49	2026-01-14	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84448-801-12	84448080112	1 TUBE in 1 CARTON (84448-801-12) / 120 mL in 1 TUBE	1 tube	2026-01-01	No	No	Current
84448-801-30	84448080130	1 TUBE in 1 CARTON (84448-801-30) / 30 mL in 1 TUBE	1 tube	2026-01-01	No	No	Current
84448-801-60	84448080160	1 TUBE in 1 CARTON (84448-801-60) / 60 mL in 1 TUBE	1 tube	2026-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Titanium Dioxide, Zinc Oxide - THG Beauty USA LLC	THG Beauty USA LLC	2025-11-27	HUMAN OTC DRUG LABEL	1