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 97 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sei Bella CC Brightening Creme Light	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6894b9d9-a5b5-4c98-e053-2991aa0a9ca2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Fair	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6892952a-d032-30bf-e053-2a91aa0a3bba	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Medium Tan	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4e8b4-36cb-6306-e053-2a91aa0a6d25	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Medium	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4ed34-f492-67a6-e053-2a91aa0a0428	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen	SUNSCREEN	Melaleuca Inc.	1f1d1575-cf37-5d66-e063-6394a90ab2a3	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Daily Hydration	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	c9bb7d33-783b-4cbb-a130-91f92d4cc137	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	a13e5326-73c3-9fa8-e053-2a95a90aae9d	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	a13e3f45-8e6f-6a3f-e053-2995a90a17d2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Deep 550 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e31a82-0cd0-5a1a-e053-2991aa0a33f8	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2dfaa-d173-e6a9-e053-2a91aa0a4663	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 300 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2e541-c583-0f12-e053-2991aa0a4ab2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30231-4fba-35d4-e053-2991aa0a33cb	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 440 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30255-5640-3b4a-e053-2991aa0ab3f7	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30255-564f-3b4a-e053-2991aa0ab3f7	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 320 C	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2e541-c596-0f12-e053-2991aa0a4ab2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e20c57-7b30-4e96-e053-2991aa0aab3e	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Pina Colada	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	16d0d2d2-b9c4-4491-8d8a-815843d342e8	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Mountain Mint	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	326d9623-0e67-43bd-83f8-ee7dfa3bdbe8	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Vanilla Bean	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	2037cc9d-b11b-47d6-8d65-c0f9decc8ba7	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Mineral Plus Sunscreen with Zinc Oxide	OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%	Melaleuca Inc.	8886cbd0-ed2b-4a2b-a724-a0d4f12296c9	2025-12-31	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