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 142 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foam Weightless Sunscreen Non-Tinted Drytouch NT	TITANIUM DIOXIDE, ZINC OXIDE	Cutis Wellness Dermatology And Dermatopathology PLLC	335ec22c-6a9a-c4d1-e063-6394a90ac0b0	2025-12-09		Exact identifier application number: M020
Mineral Sunscreen Moisturizing Non-Tinted	ZINC OXIDE	Cutis Wellness Dermatology And Dermatopathology PLLC	3360a208-5f17-a74b-e063-6294a90a13e1	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	323356ea-31a0-6ff0-e063-6294a90a135c	2025-12-09		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	32330376-5db0-202b-e063-6294a90add15	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Untinted	ZINC OXIDE	Lily Lee, MD	32354468-94a2-604b-e063-6394a90adfb5	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Tinted	ZINC OXIDE	Lily Lee, MD	32346536-f542-ef0f-e063-6394a90a0464	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Mineral Stick Untinted	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	3234b498-5b56-55f4-e063-6294a90a9b87	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Tinted	ZINC OXIDE	Lily Lee, MD	3235a696-92aa-788c-e063-6394a90a0149	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	32351db0-884c-8fa0-e063-6294a90acba2	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Untinted	ZINC OXIDE	Lily Lee, MD	3235786d-7ba9-c9ab-e063-6294a90a7f2e	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen 20% Zinc Oxide	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	31416d04-2d6f-7cf9-e063-6294a90a9806	2025-12-09	Warnings	Exact identifier application number: M020
Matte Invisible Mineral Sunscreen Non-Tinted	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	3143968a-096e-b9ac-e063-6294a90ada0d	2025-12-09	Warnings	Exact identifier application number: M020
Daily Mineral Sunscreen 20% Zinc Oxide	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	314299b1-a78b-c1bd-e063-6294a90ab43b	2025-12-09	Warnings	Exact identifier application number: M020
Sheer Satin Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	3143d8b0-4af8-f52d-e063-6294a90a926b	2025-12-09	Warnings	Exact identifier application number: M020
Matte Invisible Mineral Sunscreen	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	3142ed0f-f379-f240-e063-6294a90a5303	2025-12-09	Warnings	Exact identifier application number: M020
Sheer Non-Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	Face Collection, L.L.C.	33d83cfb-045d-141c-e063-6394a90a2e04	2025-12-09		Exact identifier application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	45875865-5e9c-d652-e063-6394a90ad5fa	2025-12-09	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Maloney Plastic Surgery Skin Care, PLLC	316b7584-c782-fe9e-e063-6394a90a76fe	2025-12-09		Exact identifier application number: M020
Transparent Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	Face Collection, L.L.C.	33dbfd9b-b90f-bb32-e063-6294a90af7dc	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Maloney Plastic Surgery Skin Care, PLLC	316b46ac-6dde-72d1-e063-6294a90a03da	2025-12-09		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