Tinted Mineral Sun Defense

Product NDC: 85581-203
11-digit product format: 855810203
Labeler code: 85581
Product ID: 85581-203_4616601b-083c-f75b-e063-6394a90a1a19
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Helen's Haven
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-01
Substance: ZINC OXIDE; TITANIUM DIOXIDE
Active strength: 38; 80 mg/g; mg/g
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: Tinted Mineral Sun Defense
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	38 mg/g
TITANIUM DIOXIDE	80 mg/g

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
36c465ea-979b-9474-e063-6394a90ab3f8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85581-203-50	Tinted Mineral Sun Defense	53 g in 1 BOTTLE, PUMP	CREAM	53		2

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 278 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Only SunX30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acme United Corporation	24c22903-8911-81d9-e063-6394a90a108b	2024-10-18	Warnings	Exact identifier application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	33f8760c-2953-44a6-9239-424fdb97a5b3	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c85e5094-d442-55a9-e053-2995a90aed12	2024-10-18	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Face	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	24c78897-3136-f24b-e063-6394a90aa80a	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f42a0b1e-038d-4fab-e053-2995a90a5364	2024-10-18	Warnings	Exact identifier application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	f451c472-1d9f-1fbc-e053-2995a90a114e	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen	ZINC OXIDE	Fruit Of The Earth, Inc.	f4490608-6cce-90f3-e053-2995a90a4930	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit Of The Earth, Inc.	f540b0f6-3e6c-43a7-e053-2a95a90aba74	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f4481bf3-6dc7-5641-e053-2a95a90ad938	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City	LIP BALM SPF 30 SUNSCREEN STICK	Fruit of the Earth, Inc.	3ec16996-ae86-4f5b-b1fd-c7b509cc5d50	2024-10-18	Warnings	Exact identifier application number: M020
Cabana Beach Club with Mentha and Essential Oils SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	f452df0c-ea8d-e25c-e053-2995a90a1143	2024-10-18	Warnings	Exact identifier application number: M020
FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	FRUIT OF THE EARTH, INC.	fa18f1a9-7a6a-856e-e053-6294a90aeafa	2024-10-18	Warnings	Exact identifier application number: M020
Cabana Beach Club with Blood Orange and Essential Oils SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	f452f94a-d2f1-60ec-e053-2995a90a8827	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f45d25d2-9305-5858-e053-2a95a90a7f7b	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit Of The Earth, Inc.	f53fff7a-ef8b-19c4-e053-2a95a90a4a2a	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Fruit Of The Earth, Inc.	fd68012d-814b-ac07-e053-6394a90afc68	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd687b34-e4c6-0458-e053-6394a90ac064	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd786a06-88b7-fa35-e053-6394a90a84a5	2024-10-18	Warnings	Exact identifier application number: M020
Chemical Sunscreen SPF50 with Antipollution	HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREEN	Swiss-American CDMO, LLC	59efb7dd-83f9-4222-9b7e-ea17ac4ece00	2024-10-18	Warnings	Exact identifier application number: M020
CVS Health SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	f0d6ac48-3d57-0f5c-e053-2a95a90a87cf	2024-10-17	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
85581-203-50	85581020350	53 g in 1 BOTTLE, PUMP (85581-203-50)	53 g	2020-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Mineral Sun Defense	Helen's Haven \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-16	HUMAN OTC DRUG LABEL	2