Sand Cloud Mineral Sunscreen

Product NDC: 83081-2045
11-digit product format: 830812045
Labeler code: 83081
Product ID: 83081-2045_4655b7b6-125c-ad40-e063-6294a90a48ce
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Sand Cloud Holdings, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-06-30
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 54; 108 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	83081-2045	83081-2045-5	D	Discontinued by firm		2026-10-20

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: Sand Cloud Mineral Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	54 mg/mL
ZINC OXIDE	108 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
ff477199-9b01-fc90-e053-6294a90a5102	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83081-2045-3	Sand Cloud Mineral Sunscreen	89 mL in 1 TUBE	LOTION	89		3
83081-2045-5	Sand Cloud Mineral Sunscreen	148 mL in 1 TUBE	LOTION	148		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83081-2045	SAND CLOUD MINERAL SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SAND CLOUD HOLDINGS, LLC]	2	Current NDC, 2 package rows	20231207_ff477199-9b01-fc90-e053-6294a90a5102.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 98 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Eucerin Daily Hydration	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	798cbf7f-b93d-49c8-b1c1-216486e57ea5	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Face immersive Hydration	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	fe0b3717-f472-3a61-e053-6394a90a44fb	2025-12-31	Warnings	Exact identifier application number: M020
NIVEA MEN Age Defense Face Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	27cbec3e-e811-6498-e063-6394a90ada49	2025-12-31	Warnings	Exact identifier application number: M020
Nivea Men Maximum Hydration Face	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	f1276b11-6683-e982-e053-2a95a90a7803	2025-12-31	Warnings	Exact identifier application number: M020
Nivea Men Sensitive Protective	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	f6cff3d1-cca5-4b3e-a481-0c4def90684c	2025-12-31	Warnings	Exact identifier application number: M020
Nivea Smoothness Lip Care	AVOBENZONE,OCTOCRYLENE	Beiersdorf Inc	c28e327d-ad39-9bd6-e053-2a95a90a04eb	2025-12-31	Warnings	Exact identifier application number: M020
BOTANICAL SOOTHING SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	00a923fe-e6da-420e-a705-4773ecc2176b	2025-12-31	Warnings	Exact identifier application number: M020
AROMA MATTE DAY SUNSCREEN SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	f822f3ec-3c57-100a-e053-6294a90ab0ec	2025-12-31	Warnings	Exact identifier application number: M020
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	8ac09149-f7e7-40a8-b306-98964d0cd6e3	2025-12-31	Warnings	Exact identifier application number: M020
CONTROL CORRECTIVE SUNSCREEN SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	e389b2bc-bb1c-443a-9bf6-c6d96380f378	2025-12-31	Warnings	Exact identifier application number: M020
CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREEN	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	61b6dab9-3378-4206-bf1f-6f385a9c882c	2025-12-31	Warnings	Exact identifier application number: M020
Blue Lizard Sensitive SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	32d78048-d281-1d80-e063-6394a90aec19	2025-12-31	Warnings	Exact identifier application number: M020
DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	ESTEE LAUDER INC	df535004-c94c-4a28-ad20-78bd1741e39f	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	Sample	Exclude flag	Status
83081-2045-3	83081204503	89 mL in 1 TUBE (83081-2045-3)	89 ml	2023-06-30	No	No	Current
83081-2045-5	83081204505	148 mL in 1 TUBE	148 ml				Historical