MedPath

YONHISDAT Sunscreen Powder

Approved
Approval ID

3aeb0f66-d613-9bc8-e063-6294a90a691d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

PANERGYTEK USA INC

DUNS: 122142088

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

titanium dioxide, zinc oxide powder

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85950-002
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
titanium dioxide, zinc oxide powder
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (16)

MICAInactive
Code: V8A1AW0880
Classification: IACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILInactive
Code: ZBP1YXW0H8
Classification: IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMERInactive
Code: 9NH1UDD2RR
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 19.5 g in 100 g
Code: 15FIX9V2JP
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
LOPHATHERUM GRACILE LEAFInactive
Code: R417138GE9
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
DAUCUS CAROTA SATIVA (CARROT) SEED OILInactive
Code: 595AO13F11
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
CI 77491Inactive
Code: 1K09F3G675
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CI 77492Inactive
Code: EX438O2MRT
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
ZINC OXIDEActive
Quantity: 24 g in 100 g
Code: SOI2LOH54Z
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/27/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/27/2025

Apoly liberally i5 mnutes before sunexoosure.pants, hats andsunglasses. Children under 6months of age: ask a doctor
Reapph: Aler 80 minues oswinming or sneaing immetlaletater ionel dning Atleast eveny2hours.Sun precion leasures Spending ime in the sun increasesyour isk oifshincancer and eaty skinaging T
decrease this rsk requlanuse a sunsren uith a bradspecnum spf value of 15 or higtherAnd ohersun prolecion measureshclud ng imtime ihthe sun especdaly fom 10am.2am.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/27/2025

TITANIUM DIOXIDE

19.5%

ZINC OXIDE24%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/27/2025

Sunscreen

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/27/2025

Helps prevent sunbum fused as directed with other sunprotection measures(see Directions)decreases the risk of skin cancer andeary skin aging caused by the sun

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/27/2025

Apoly liberally i5 mnutes before sunexoosure.pants, hats andsunglasses. Children under 6months of age: ask a doctor
Reapph: Aler 80 minues oswinming or sneaing immetlaletater ionel dning Atleast eveny2hours.Sun precion leasures Spending ime in the sun increasesyour isk oifshincancer and eaty skinaging T
decrease this rsk requlanuse a sunsren uith a bradspecnum spf value of 15 or higtherAnd ohersun prolecion measureshclud ng imtime ihthe sun especdaly fom 10am.2am.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/27/2025

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/27/2025

Protect this product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/27/2025

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer
Aluminum hydroxide
Mica
Lophatherum Gracile Leaf
Dimethicone
Triethoxycaprylylsilane
Stearic Acid
Tocopherol
CI 77492
CI 77491
Sodium Benzoate
Potassium Sorbate
Daucus Carota Sativa (Carrot) Seed Oil
Lavandula Angustifolia (Lavender) Oil

WARNINGS SECTION

LOINC: 34071-1Updated: 7/27/2025

For enemal use onyDo nd use on damaged or icken shnwmen using his poductkep ou oeyes Rise wth walerto remove slop use and ask adoco lrash occursKeep out d reachof thilien. producs
swallowed. get medical helpor contact a Potson Control Center rightaway

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YONHISDAT Sunscreen Powder - FDA Drug Approval Details