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Pure velocity MINERAL SUNSCREEN SPF 50

Approved
Approval ID

4003047b-bc55-bb11-e063-6294a90aa433

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Guangzhou Haishi 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.

TITANIUM DIOXIDE,ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60771-0032
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
TITANIUM DIOXIDE,ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (31)

TRITICUM VULGARE (WHEAT) GERMInactive
Code: YR3G369F5A
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
TRITICUM VULGARE (WHEAT) GERM OILInactive
Code: 14C97E680P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 3.9 g in 100 mL
Code: 15FIX9V2JP
Classification: ACTIB
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
CETEARYL GLUCOSIDEInactive
Code: 09FUA47KNA
Classification: IACT
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
PAEONIA ALBIFLORA FLOWERInactive
Code: R73687A534
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
ALOE FEROX LEAF JUICEInactive
Code: 0D145J8EME
Classification: IACT
CENTELLA ASIATICA ROOTInactive
Code: 8MXU1P42J0
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
PARFUMIDINEInactive
Code: A2Q2LHC6MA
Classification: IACT
1,3-BETA-GLUCAN SYNTHASE COMPONENT FKS1Inactive
Code: 4FRY3LJG0V
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
TREHALOSEInactive
Code: B8WCK70T7I
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
ETHYLHEXYL SALICYLATEInactive
Code: 4X49Y0596W
Classification: IACT
ZINC OXIDEActive
Quantity: 2.7 g in 100 mL
Code: SOI2LOH54Z
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CETEARETH-22Inactive
Code: 28VZG1E234
Classification: IACT
LIMNANTHES ALBA (MEADOWFOAM) SEED OILInactive
Code: 412ZHA4T4Y
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIPOTASSIUM GLYCYRRHIZATEInactive
Code: CA2Y0FE3FX
Classification: IACT
MACADAMIA TERNIFOLIA SEED OILInactive
Code: 515610SU8C
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

TITANIUM DIOXIDE

ZINC OXIDE

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

INACTIVE INGREDIENT SECTION

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

Inactive ingredients

WATER
ASCORBIC ACID
TITANIUM DIOXIDE
ZINC OXIDE
NIACINAMIDE
PROPYLENE GLYCOL
GLYCERIN
TREHALOSE
ALLANTOIN
SODIUM HYALURONATE
DIPOTASSIUM GLYCYRRHIZATE
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL
MACADAMIA TERNIFOLIA SEED OIL
TRITICUM VULGARE (WHEAT) GERM OIL
ETHYLHEXYL SALICYLATE
C12-15 ALKYL BENZOATE
CETEARYL ALCOHOL
CETEARYL GLUCOSIDE
CETEARETH-21
DIMETHICONE
TOCOPHERYL ACETATE
BISABOLOL
XANTHAN GUM
ETHYLHEXYLGLYCERIN
CHLORPHENESIN
HYDROLYZED BETA-GLUCAN
PAEONIA ALBIFLORA ROOT EXTRACT
TRITICUM VULGARE (WHEAT) GERM EXTRACT
CENTELLA ASIATICA ROOT EXTRACT
ALOE FEROX LEAF EXTRACT
PARFUM

DOSAGE & ADMINISTRATION SECTION

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

Dosage & administration

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

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Pure velocity MINERAL SUNSCREEN SPF 50 - FDA Drug Approval Details