TiZO Photoceutical Environmental Skin Protectant

Product NDC: 58892-105
11-digit product format: 588920105
Labeler code: 58892
Product ID: 58892-105_26e5b5e4-fbb5-2d08-e063-6394a90a95d5
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: GEL
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-06-20
Substance: DIMETHICONE
Active strength: 30 mg/mL
Pharmacologic classes: Skin Barrier Activity [PE]
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: TiZO Photoceutical Environmental Skin Protectant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	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
84a3299d-9b98-492e-a83f-ebd72ec58f8d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-105-30	TiZO Photoceutical Environmental Skin Protectant	1 in 1 CARTON	GEL	1		3
58892-105-30	TiZO Photoceutical Environmental Skin Protectant	29 mL in 1 BOTTLE	GEL	29		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-105	TIZO PHOTOCEUTICAL ENVIRONMENTAL SKIN PROTECTANT (DIMETHICONE) GEL [FALLIEN COSMECEUTICALS, LTD]	3	Current NDC, Legacy NDC, 2 package rows	20241116_84a3299d-9b98-492e-a83f-ebd72ec58f8d.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 280 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented	ZINC OXIDE	H.E.B.	f58ed2f9-67c3-ce91-e053-2995a90a1229	2024-10-15	Warnings	Exact identifier application number: M020
HEB Shimmer Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5930029-4c96-2576-e053-2995a90a7bed	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Birthday Cake Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5a3313e-4935-1ce3-e053-2a95a90a6ad1	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 White Gardenia Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b6caf2-ebff-79fb-e053-2995a90ac2f8	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 For Men Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f59461e3-9521-6a7b-e053-2a95a90a73b8	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pink Peony Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f5a2c266-6fc9-21ae-e053-2995a90aec0e	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pink Peony Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b7172a-b8fc-0d11-e053-2a95a90a9f73	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Peach Bellini Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5cbac04-361f-9226-e053-2995a90a2d7b	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Cucumber Water Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5d933cf-3461-8b03-e053-2a95a90ad79f	2024-10-15	Warnings	Exact identifier application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	H.E.B	f6ce4ea0-d92f-368c-e053-6294a90a2a81	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 White Gardenia Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f5a2702c-5451-58a1-e053-2a95a90adb8e	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5cb5f9a-6691-37c3-e053-2a95a90a9af0	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Rosewater Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5db7ec6-0e9b-7044-e053-2a95a90a1e48	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pomegranate Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b48729-43d3-72b4-e053-2995a90a9d85	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 For Men Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b682aa-a194-09ff-e053-2a95a90ade73	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Birthday Cake Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b755af-2bd3-33cf-e053-2a95a90a9961	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Watermelon Serbert Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b77cc0-1ed5-c4ae-e053-2a95a90abc1a	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6e0db20-594b-30a8-e053-6394a90a7164	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6dfe973-bd88-e0e4-e053-6394a90ac927	2024-10-15	Warnings	Exact identifier application number: M020
HEB Face Primer 30 Sunscreen Face Primer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H-E-B	f6e29c93-9fd9-36c6-e053-6394a90a1747	2024-10-15	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58892-105-30	58892010530	1 BOTTLE in 1 CARTON (58892-105-30) / 29 mL in 1 BOTTLE	1 bottle	2019-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-11-14	HUMAN OTC DRUG LABEL	3