Florida Babe Everyday Tinted Replenishing Daily Protection

Product NDC: 85337-208
11-digit product format: 853370208
Labeler code: 85337
Product ID: 85337-208_4589f5b8-cede-bc9e-e063-6394a90a6c17
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Tichy Anesthesia PA
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-12-09
Substance: ZINC OXIDE
Active strength: 160 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: Florida Babe Everyday Tinted Replenishing Daily Protection
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/g

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
3231f1fe-51b3-b2e7-e063-6394a90a2758	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85337-208-15	Florida Babe Everyday Tinted Replenishing Daily Protection	1.5 g in 1 PACKET	CREAM	1.5		2
85337-208-50	Florida Babe Everyday Tinted Replenishing Daily Protection	50 g in 1 BOTTLE, PUMP	CREAM	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85337-208	FLORIDA BABE EVERYDAY TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [TICHY ANESTHESIA PA]	1	Current NDC, 1 package rows	20250406_31e63876-3e39-adc6-e063-6394a90ab146.zip
85337-208	FLORIDA BABE EVERYDAY TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [TICHY ANESTHESIA PA]	1	Current NDC, 1 package rows	20250409_3231f1fe-51b3-b2e7-e063-6394a90a2758.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 244 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	fmg Co.Ltd	f114e45c-6c31-2382-e053-2995a90ac754	2025-01-01	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9c-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9e-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	f8377d02-6c58-c240-e053-6294a90a44c0	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d67faeb3-0b73-5b6e-e053-2a95a90aac2b	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	02e63ed6-1f49-45c0-e063-6394a90a58bf	2025-01-01	Warnings	Exact identifier application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d2fadd51-6bd8-ae70-e053-2995a90a6213	2025-01-01	Warnings	Exact identifier application number: M020
Jergens Natural Glow Face Moisturizer Medium to Deep Skin Tones	AVOBENZONE,OCTISALATE, OCTOCRYLENE	Kao USA Inc.	ff601f5c-b8ed-ee21-e053-6294a90aadba	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d309eebc-44f4-bce6-e053-2995a90a3bd2	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a3bcb-5113-0a85-e053-2995a90a3937	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30a9f96-f99b-4610-e053-2995a90a3f91	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a7ecc-ea54-d1b9-e053-2995a90a7017	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a87b9-90f9-35b2-e053-2995a90aea2c	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30ab7a5-d38c-ba62-e053-2995a90a57fd	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6e82b4e-ce83-0ca2-e053-2a95a90a88de	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	LG H&H Co., Ltd.	0166d193-fc4d-51f7-e063-6294a90aaf32	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6e831a1-c82f-3e1f-e053-2a95a90ae1f6	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6e82b4e-ce84-0ca2-e053-2a95a90a88de	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	016798a8-4275-47d0-e063-6294a90a5aca	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	LG H&H Co., Ltd.	f1166cb4-b471-7043-e053-2a95a90a7fa7	2025-01-01	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
85337-208-15	85337020815	1.5 g in 1 PACKET (85337-208-15)	1.5 g	2024-12-09	Yes	No	Current
85337-208-50	85337020850	50 g in 1 BOTTLE, PUMP (85337-208-50)	50 g	2024-12-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Florida Babe Everyday Tinted Replenishing Daily Protection	Tichy Anesthesia PA \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-09	HUMAN OTC DRUG LABEL	2
Florida Babe Everyday Tinted Replenishing Daily Protection	Tichy Anesthesia PA \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-09	HUMAN OTC DRUG LABEL	2