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SENSITIVE POCKET SUN

Approved
Approval ID

36ac412f-e31f-6906-e063-6394a90a4a3d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 14, 2025

Manufacturers
FDA

Shantou Oushiya Biotechnology Co., Ltd

DUNS: 726173915

Products 1

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

SENSITIVE POCKET SUN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85819-771
Product Classification
G
Generic Name
SENSITIVE POCKET SUN
Product Specifications
Route of AdministrationPERCUTANEOUS
Effective DateJune 14, 2025
FDA Product Classification

INGREDIENTS (16)

ETHYLHEXYL TRIAZONEInactive
Code: XQN8R9SAK4
Classification: IACT
POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
SODIUM POTASSIUM ALUMINUM SILICATEInactive
Code: Z6C6FF3Y9R
Classification: IACT
TALCActive
Quantity: 15 mg in 1 1
Code: 7SEV7J4R1U
Classification: ACTIB
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEInactive
Code: PWZ1720CBH
Classification: IACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEInactive
Code: ANQ870JD20
Classification: IACT
SYNTHETIC WAX (540 MW)Inactive
Code: DW2TC44JRY
Classification: IACT
ETHYLHEXYL SALICYLATEInactive
Code: 4X49Y0596W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
CYCLOPENTASILOXANEActive
Quantity: 26.5 mg in 1 1
Code: 0THT5PCI0R
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/14/2025

2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/14/2025

Rotate about 3mm and apply evenly to areas that are easily exposed to ultraviolet rays.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/14/2025

TRIETHOXYCAPRYLYLSILANE,DIMETHICONE,ETHYLHEXYL PALMITATE,SYNTHETIC WAX,POLYETHYLENE,ETHYLHEXYL SALICYLATE,TITANIUM DIOXIDE,SILICA,DIMETHICONE,MICROCRYSTALLINE WAX,BEESWAX,OCTYLDODECANOL,ETHYLHEXYL TRIAZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/14/2025

Protect the skin from UV damage

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/14/2025

SPF50+,PA++++

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/14/2025

CYCLOPENTASILOXANE,TALC,

WARNINGS SECTION

LOINC: 34071-1Updated: 6/14/2025

Please keep it out of reach of infants and young children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/14/2025

KEEP OUT OF REACH OF CHILDREN SECTION

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SENSITIVE POCKET SUN - FDA Drug Approval Details