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Sun Zapper - Kids pure zinc sunscreen SPF50

Sun Zapper - Kids pure zinc sunscreen SPF50

Approved
Approval ID

3ee4410b-46d8-1059-e063-6394a90a7f96

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

VEGANIC SKN LIMITED

DUNS: 743536682

Products 1

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

Zinc Oxide sunscreen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83252-123
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide sunscreen
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (18)

COCO-CAPRYLATE/CAPRATEInactive
Code: 8D9H4QU99H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYGLYCERYL-3 RICINOLEATEInactive
Code: MZQ63P0N0W
Classification: IACT
GLYCERYL STEARATE CITRATEInactive
Code: WH8T92A065
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM HINOKITIOLInactive
Code: 5MPS47D679
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
COCONUT ALKANESInactive
Code: 1E5KJY107T
Classification: IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OILInactive
Code: 3W1JG795YI
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
ISOSTEARIC ACIDInactive
Code: X33R8U0062
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
ZINC OXIDEActive
Quantity: 25 kg in 100 kg
Code: SOI2LOH54Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

Label - 100g

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

kindly refer to label picture

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/16/2025

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

Kindly refer to Label

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/16/2025

See ingredients on label

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 9/16/2025

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Zinc oxide - 25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

For external use only.

Do not use on damaged r broken skin.

When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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