Calming Primer SPF 20

Product NDC: 68078-040
11-digit product format: 680780040
Labeler code: 68078
Product ID: 68078-040_54f6f676-1299-4c63-b090-fc1bc26b76eb
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: LIQUID
Route: TOPICAL
Labeler: Colorescience
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 54; 54 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: Calming Primer SPF 20
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	54 mg/mL
ZINC OXIDE	54 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
d681cdb5-307e-4a2a-8e1d-2b29131d48d0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68078-040-01	Calming Primer SPF 20	30 mL in 1 BOTTLE	LIQUID	30		2
68078-040-01	Calming Primer SPF 20	1 in 1 CARTON	LIQUID	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68078-040	CALMING PRIMER SPF 20 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]	2	Current NDC, Legacy NDC, 2 package rows	20241215_d681cdb5-307e-4a2a-8e1d-2b29131d48d0.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 257 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinka SPF 30 Clear Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Zinka, Inc	c054ac39-d03f-17c1-e053-2a95a90aa5ef	2024-12-15	Warnings	Exact identifier application number: M020
QC SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	CDMA	f82080b1-ef90-a027-e053-6294a90a19f2	2024-12-15	Warnings	Exact identifier application number: M020
QC SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%	CDMA	f80ceb05-0bd4-1355-e053-6294a90afb19	2024-12-15	Warnings	Exact identifier application number: M020
Lip Shine SPF35 Sunscreen	ZINC OXIDE	Colorescience	3a6506c4-1ba9-493a-a4c8-e5f9c60d221b	2024-12-13	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEP	ZINC OXIDE	COSMAX USA, CORPORATION	292165af-545d-db43-e063-6394a90ad183	2024-12-13	Warnings	Exact identifier application number: M020
Tinted Lip Cream SPF 15	ZINC OXIDE	COSMAX USA, CORPORATION	29227121-e579-8eea-e063-6394a90a302f	2024-12-13	Warnings	Exact identifier application number: M020
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONE	Bobbi Brown Professional Cosmetics Inc.	03372376-ef03-943d-e063-6394a90a52ee	2024-12-13	Warnings	Exact identifier application number: M020
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE	Bobbi Brown Professional Cosmetics Inc.	fbd04b66-738b-2762-e053-6394a90a8b72	2024-12-13	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	33f43f14-8e0b-41b1-8ad0-5723d2a7bf19	2024-12-13	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 8 Sunscreen	ZINC OXIDE	Absolutely Natural	a26217cf-22ab-4c39-980a-b73467e16b91	2024-12-13	Warnings	Exact identifier application number: M020
Calming Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	d681cdb5-307e-4a2a-8e1d-2b29131d48d0	2024-12-13	Warnings	Exact identifier application number: M020 ndc (product): 68078-040
Absolutely Natural Broad Spectrum SPF 15 Sunscreen	ZINC OXIDE	Absolutely Natural	8084a3ee-fe31-4cb4-8d3c-e4035d29e561	2024-12-13	Warnings	Exact identifier application number: M020
Mineral Corrector Palette SPF 20 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	ab70122f-bd68-4781-841f-dc83284e1403	2024-12-13	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	0a0654cc-ad47-2167-e063-6294a90a52f4	2024-12-12	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40	ZINC OXIDE, TITANIUM DIOXIDE	Babo Botanicals, Inc.	f8adda52-e909-1905-e053-6294a90a3c78	2024-12-12	Warnings	Exact identifier application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30	ZINC OXIDE	Babo Botanicals, Inc.	f8b1ea3a-d62e-e00d-e053-6394a90a5689	2024-12-12	Warnings	Exact identifier application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	f8b272f6-8726-de1d-e053-6294a90a7b1e	2024-12-12	Warnings	Exact identifier application number: M020
Babo Botanicals Super Shield Sport Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	e3ca7840-4882-d605-e053-2a95a90af6ab	2024-12-12	Warnings	Exact identifier application number: M020
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow	MINERAL SUNSCREEN	Babo Botanicals, Inc.	ab39d9f0-d869-6f33-e053-2995a90a08d4	2024-12-12	Warnings	Exact identifier application number: M020
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	88dedeb8-963f-5849-e053-2995a90aab72	2024-12-12	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
68078-040-01	68078004001	1 BOTTLE in 1 CARTON (68078-040-01) / 30 mL in 1 BOTTLE	1 bottle	2020-01-01	0000-00-00	No	No	Current