INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50

Product NDC: 16555-008
11-digit product format: 165550008
Labeler code: 16555
Product ID: 16555-008_26a76872-0814-5d6f-e063-6394a90aa63e
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE and ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: DARPHIN DIST.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-07-15
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 63; 40 mg/mL; mg/mL
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: INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	63 mg/mL
ZINC OXIDE	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	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
91277514-4db0-4b40-b95a-3530cac711df	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16555-008-01	2022-08-05	C162847	48780-1	e4f33bdf-a161-d8a0-e053-dadaa90a6e4e	INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50
16555-008-01	2022-07-29	C162847	48780-1	e4f33bdf-a161-d8a0-e053-dadaa90a6e4e	INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16555-008-01	INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50	30 mL in 1 BOTTLE	LOTION	30		9
16555-008-01	INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50	1 in 1 CARTON	LOTION	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16555-008	INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [DARPHIN DIST.]	9	Current NDC, Legacy NDC, 2 package rows	20241114_91277514-4db0-4b40-b95a-3530cac711df.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 147 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Based Foam Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32465271-abb9-d03f-e063-6294a90a990e	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32486bfb-0cc8-0283-e063-6394a90a9967	2025-12-08		Exact identifier application number: M020
Harrys Daily Facial SPF Broad Spectrum	ZINC OXIDE	Harry's, Inc.	39fdde34-45ec-bc22-e063-6394a90a7dce	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Brightening plus Tint	ZINC OXIDE	ZEN DERMATOLOGY, INC.	31e32e9c-9e0b-b678-e063-6294a90a66f5	2025-12-08		Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine plus Tint	ZINC OXIDE	Zen Dermatology, Inc.	31576340-cb11-d944-e063-6294a90adef2	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine - No Tint	TITANIUM DIOXIDE, ZINC OXIDE	Zen Dermatology, Inc.	31572a16-5f60-565f-e063-6394a90ab8c9	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Face and Body	ZINC OXIDE	Zen Dermatology, Inc.	31e376b4-098f-34d7-e063-6394a90a1772	2025-12-08		Exact identifier application number: M020
AcneFix Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	315894b7-ac1b-0982-e063-6294a90ab879	2025-12-08		Exact identifier application number: M020
Shunly Natural Cover SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care	a64e373b-b3f6-4024-b5f5-253783485cd6	2025-12-08	Warnings	Exact identifier application number: M020
AcneFix Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	31583c7e-365a-d899-e063-6394a90aa63f	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334ec844-5560-50f7-e063-6394a90a01be	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334f90d6-68e5-db37-e063-6294a90a5fb1	2025-12-08		Exact identifier application number: M020
Skin Apeel Pure Protect SPF 40 Broad Spectrum	ZINC OXIDE	Skin Apeel, Inc.	18e78c7f-1523-a4f4-e063-6394a90aed97	2025-12-08	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c44baf4-9555-faad-e063-6294a90ab24f	2025-12-08	Warnings	Exact identifier application number: M020
Glow Stick	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c54b857-c017-a953-e063-6394a90a38df	2025-12-08	Warnings	Exact identifier application number: M020
Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c545e55-3f55-842b-e063-6394a90ae48e	2025-12-08	Warnings	Exact identifier application number: M020
Bare Barrier Sport	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c580794-eda3-de57-e063-6294a90a0303	2025-12-08	Warnings	Exact identifier application number: M020
Flawless Brightening Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Flawless Skin Care LLC	312e9ca0-a388-a546-e063-6294a90a15d6	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, protect	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2f8859cf-8277-6ea9-e063-6294a90a1a75	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2fb19ed7-8cee-ce80-e063-6394a90ad3dc	2025-12-08	Warnings	Exact identifier application number: M020

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16555-008-01	16555000801	1 BOTTLE in 1 CARTON (16555-008-01) / 30 mL in 1 BOTTLE	1 bottle	2017-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50	DARPHIN DIST. \| Estee Lauder Companies Inc. \| Estee Lauder Cosmetics Ltd. \| The Estee Lauder Inc	2024-11-11	HUMAN OTC DRUG LABEL	9