Tinted Sunscreen

Product NDC: 85331-203
11-digit product format: 853310203
Labeler code: 85331
Product ID: 85331-203_45af23fa-cc5a-1a7e-e063-6394a90acf71
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Scottsdale Skin Boutique and Dermatology Pllc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-07-20
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 80; 38 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Tinted Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	80 mg/g
ZINC OXIDE	38 mg/g

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
34a52011-b781-75cf-e063-6394a90ae0f4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85331-203-15	Tinted Sunscreen	15 g in 1 PACKET	CREAM	15		2
85331-203-50	Tinted Sunscreen	53 g in 1 BOTTLE, PUMP	CREAM	53		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85331-203	TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]	1	Current NDC, 1 package rows	20250510_34a52011-b781-75cf-e063-6394a90ae0f4.zip
85331-203	TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]	1	Current NDC, 1 package rows	20250510_34a632f5-4458-e335-e063-6394a90a9bcb.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
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
85331-203-15	85331020315	15 g in 1 PACKET (85331-203-15)	15 g	2022-07-28	Yes	No	Current
85331-203-50	85331020350	53 g in 1 BOTTLE, PUMP (85331-203-50)	53 g	2022-07-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Sunscreen	Scottsdale Skin Boutique and Dermatology Pllc \| Custom Analytics LLC \| Fragrance Manufacturing Inc \| Fallien Cosmeceuticals Ltd.	2025-12-11	HUMAN OTC DRUG LABEL	2
Tinted Sunscreen	Scottsdale Skin Boutique and Dermatology Pllc \| Custom Analytics LLC \| Fragrance Manufacturing Inc \| Fallien Cosmeceuticals Ltd.	2025-12-11	HUMAN OTC DRUG LABEL	2