FDA.reportPublic FDA data

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY

Product NDC
14141-307
11-digit product format
141410307
Labeler code
14141
Product ID
14141-307_3ce46bfb-8d6d-05f6-e063-6394a90aac2f
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
BEL STAR S A
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-07
Substance
ZINC OXIDE; OCTINOXATE
Active strength
39.2; 25 mg/g; mg/g
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
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE39.2 mg/g
OCTINOXATE25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea39a1c0-6b12-77ba-e053-2995a90a7314Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-307-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY1 in 1 CARTONSTICK14
14141-307-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY3 g in 1 TUBESTICK34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-307CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 BERRY CREAMY (OCTINOXATE, ZINC OXIDE) STICK [BEL STAR S A]3Current NDC, Legacy NDC, 2 package rows20240913_ea39a1c0-6b12-77ba-e053-2995a90a7314.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 266 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 SunscreenZINC OXIDEArbonne International, LLCc172f793-3f7a-47b3-9db1-58487b8ad66c2024-11-12WarningsExact identifier
application number: M020
Hello Sunday The Everyday One Face Moisturiser SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7e1aa2-7054-435d-e063-6394a90a2d082024-11-12WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.be3c7ef2-dd08-0f1a-e053-2995a90ae14c2024-11-12WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTDfbafa468-fce0-4597-bcb0-a816dc71ec7c2024-11-12WarningsExact identifier
application number: M020
Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.beb0b43b-a90d-05ae-e053-2995a90a1d8e2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Ivory to Fair 10OCTINOXATE AND OCTISALATEKenvue Brands LLC0e489dec-9c7e-48c1-98cb-1aec91884a162024-11-11WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10OCTINOXATE AND OXYBENZONEKenvue Brands LLCe77c07d4-4e64-4000-9e7a-963aa6c6448c2024-11-11WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLC54a3b677-4510-4191-8386-ccdd10ccfcaa2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior504d8118-f84d-4f3f-abd1-463f3780a2cb2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0d4e667a-cf93-4f6d-8565-ecfa9a18cfbf2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcb1d643e-34dc-48f2-aecd-ba2a35dc34032024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior097b3d7b-5dff-4206-99f1-6573902232e92024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora621a610-7dd2-4ccd-bc48-8671e4f4a8872024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43296d42-7bc2-4073-8231-4a7921f9ebe32024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5ee35643-bd86-4d55-914a-96f4670bfd072024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf519aa3f-11a1-4941-bf31-47ac11f5a7032024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03f0ad8b-25b1-4b01-abad-d1b0851e15c52024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diora6363bc5-6a99-4412-ba62-ec66054e2c712024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9b2133dd-5dd0-476d-98c7-7f2e72024de72024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5b74e312-39b1-4b11-a678-b4fccea845812024-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14141-307-01141410307011 TUBE in 1 CARTON (14141-307-01) / 3 g in 1 TUBE1 tube2022-10-070000-00-00NoNoCurrent