Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen

Product NDC: 64657-007
11-digit product format: 646570007
Labeler code: 64657
Product ID: 64657-007_41d75815-e282-bf88-e063-6294a90afeff
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Naturopathica Holistic Health
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-23
Substance: ZINC OXIDE
Active strength: 150 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: Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
41d75815-e281-bf88-e063-6294a90afeff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64657-007-01	Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen	65 mL in 1 TUBE	LOTION	65		1
64657-007-02	Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen	1 in 1 CARTON	LOTION	1		1

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 78 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	27bb6424-9aa6-408a-a9f4-874cb60c8f1f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ea170049-ec16-4c9d-a73d-368f6b747d57	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b6fb14f0-a3e3-4545-bb4a-f9c27190b11b	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6cb14dcf-8b70-40c3-882b-063d8922ce4c	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e4dbfd77-0eec-4d1a-94d6-4daca096d8c7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72569958-cd7d-4d52-add4-2b13706e1b1e	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	0f5aa600-4168-419b-95d7-569764b5f0b9	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e5ab0cd9-ae7f-4558-b5ab-e0b582677224	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b9fa3bb9-12ec-40d8-b433-a96d9d00cc90	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f7b2e348-2c7f-4ff5-8ab0-a3475c9d1f26	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	69924eb8-a8ca-4ea0-b087-c865a6a1313f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5cafac21-fb2d-4d63-a7fe-01bf53b941e8	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bfc27e8d-e59b-46f7-aec9-2a96a00a7c1c	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8fd56c86-ef37-4f31-87d1-6283a19c8424	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	91b62ba7-2deb-47e6-b9af-25bb459b4d75	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6eec7554-38ed-48d4-916d-ab3660fbf703	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	939e6d5c-3dd7-4b01-af18-697dc4ba2d99	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7149784b-3548-4643-abf6-58fde237bb98	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	061181d8-5387-4541-a7d7-426cba5997a0	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f6ad554a-4795-4149-b066-c53a0989470e	2026-01-16	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
64657-007-01	64657000701	65 mL in 1 TUBE	65 ml				Historical
64657-007-02	64657000702	1 TUBE in 1 CARTON (64657-007-02) / 65 mL in 1 TUBE (64657-007-01)	1 tube	2025-10-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide - Naturopathica Holistic Health	Naturopathica Holistic Health	2025-10-23	HUMAN OTC DRUG LABEL	1