MedPath

Pure velocity TINTED SUNSCREEN SPF 50

Approved
Approval ID

40049f9d-7057-05c2-e063-6294a90acbba

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Guangdong Aimu Biological Technology Co., Ltd

DUNS: 421262738

Products 1

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

ZINC OXIDE,TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60771-0035
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE,TITANIUM DIOXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (19)

ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (35/65 W/W; 10000000 PA.S)Inactive
Code: TEU31AO9BN
Classification: IACT
DIPROPYLENE GLYCOL CAPRYLATEInactive
Code: CJ981S4H3T
Classification: IACT
POLYGLYCERYL-2 TRIISOSTEARATEInactive
Code: 68DUY2D39A
Classification: IACT
PHENYL TRIMETHICONEInactive
Code: DR0K5NOJ4R
Classification: IACT
ABIES PROCERA LEAFInactive
Code: J2Y55K311I
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive
Code: H895X08VNQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ZINC OXIDEActive
Quantity: 3 g in 100 g
Code: SOI2LOH54Z
Classification: ACTIB
DICAPRYLYL CARBONATEInactive
Code: 609A3V1SUA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Code: 724GKU717M
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 2.5 g in 100 g
Code: 15FIX9V2JP
Classification: ACTIB
DIPALMITOYLPHOSPHATIDYLGLYCEROL, DL-Inactive
Code: VA9U6BR3SB
Classification: IACT
BENTONITEInactive
Code: A3N5ZCN45C
Classification: IACT
ALUMINUM HEXAFLUOROSILICATEInactive
Code: E7I96VX9N6
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUMInactive
Code: 2C1F12C6AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

Label.

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Uses

If used as directed with other sun protection measures(see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active Ingredients

ZINC OXIDE
TITANIUM DIOXIDE

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose

SUNSCREEN

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

For external use only

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/30/2025

Stop Use

Rinse with wate to remove.
Stop use and ask doctor if rash occurs.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/30/2025

Do Not Use

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/30/2025

When Using

When using this product keep out of eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/30/2025

Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

Dosage & administration

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive ingredients

WATER
GLYCEROL
PROPYLENE GLYCOL
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
POLYGLYCERYL-2 TRIISOSTEARATE
PHENYL TRIMETHICONE
DICAPRYLYL CARBONATE
ETHYLHEXYL METHOXYCINNAMATE
TRIMETHYLSILOXYSILICATE
CERA ALBA
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
BENTONITE
SODIUM CHLORIDE
ASCORBIC ACID POLYPEPTIDE
CERAMIDE NP
SPHINGOMONAS FERMENT EXTRACT
SILICA
MAGNESIUM STEARATE
PEG-30 DIPOLYHYDROXYSTEARATE
XANTHAN GUM
SODIUM HYALURONATE
BISABOLOL
TOCOPHEROL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT
TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT
LILIUM CANDIDUM FLOWER EXTRACT
DENDROBIUM NOBILE EXTRACT
STEPHANIA TETRANDRA EXTRACT
TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT
SAURURUS CHINENSIS LEAF/ROOT EXTRACT
CI 77492
CI 77491
CI 77499
PARFUM

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