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SPF 30 Mineral Whipped Creams Shimmer

Approved
Approval ID

3d510061-eeb6-990c-e063-6394a90a30a0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Aopline Health Industry Technology (Guangzhou) Co., Ltd.

DUNS: 715076108

Products 1

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

ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82723-030
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (26)

HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
GENTIANA SCABRA ROOTInactive
Code: GXZ33VNT92
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ZINC OXIDEActive
Quantity: 15 g in 100 mL
Code: SOI2LOH54Z
Classification: ACTIB
OKRAInactive
Code: 51ME2L7STL
Classification: IACT
PEG-7 GLYCERYL COCOATEInactive
Code: VNX7251543
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
DIPOTASSIUM GLYCYRRHIZATEInactive
Code: CA2Y0FE3FX
Classification: IACT
CALCIUM SODIUM BOROSILICATEInactive
Code: 4MM76N4WMY
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70)Inactive
Code: 96YYQ5TK1K
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
PEG-12 DIMETHICONEInactive
Code: ZEL54N6W95
Classification: IACT
BUTANEInactive
Code: 6LV4FOR43R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PEG-100 MONOSTEARATEInactive
Code: YD01N1999R
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
PROPANEInactive
Code: T75W9911L6
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SILVERInactive
Code: 3M4G523W1G
Classification: IACT
ISOBUTANEInactive
Code: BXR49TP611
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/27/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2025

1.Avoid contact with eyes. lf it gets into eye accidentally, please rinse with clean water 2. This product is pressure pocked. Do not impact. Keep away from fire out of reach of children.3. Due to differences in human constitution, this product may have adheres reactions an a few people you feel uncontactable, please stop using
4. Do not puncture the product and empty cans or show then into fire.5. Please store in a dry and place below40℃, avoid high temperature and direct sunlight

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/27/2025

Zinc Oxide(nano) 15%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/27/2025

Water (Aqua)
Butane
Isobutane
Propane
Glycerin
PEG-17 Dimethicone
Propylene Glycol
Stearic Acid
Palmitic Acid
Triethanolamine
Glyceryl Stearate
PEG-100 Stearate
PEG-7 Glyceryl Cocoate
Jojoba Wax PEG-120 Esters
Cetearyl Alcohol
Hydroxyacetophenone
1,2-Hexanediol
Butylene Glycol
Gentiana Scabra Root Extract
Dipotassium Glycyrrhizate
Calcium SodiumBorosilicate
Silver
Sodium Hyaluronate
Disodium EDTA
Hibiscus Esculentus Fruit Extract

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/27/2025

Helps prevent sunbum, if used as directed withother sun protection measures (see Direciions), decreasesthe risk of skin cancer and eary aging caused by the sun

WARNINGS SECTION

LOINC: 34071-1Updated: 8/27/2025

For extemal use onl,.
Do not use on damaged or broken skn,
When using this product keep out of cyes, Rinse withwater to remowe,
Siop use and ask a doctor if rash cccurs.Keep out of reach of children, lf product is swalkawed, getmedical help or contact a Potson Conirol Centre right away.Wlay stain some fabrics.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/27/2025

keep out of children to use it

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/27/2025

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/27/2025

Directions: Apply liberaly 15 minues before sunexposure, e Reapply: After 80 minutes of swimming or seating,. lmmedabely after touel drying.. At leastevery 2 hours,

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/27/2025

Apply liberaly 15 minues before sunexposure,

Reapply: After 80 minutes of swimming orsseating,

lmmedabely after touel drying.. At leastevery 2 hours,

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SPF 30 Mineral Whipped Creams Shimmer - FDA Drug Approval Details