MedPath

Sky and Sol Sunscreen SPF 50

Approved
Approval ID

2d490531-af38-87d0-e063-6394a90acf49

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 25, 2025

Manufacturers
FDA

Delta Ecommerce LLC

DUNS: 118430341

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 Code84632-0503
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 25, 2025
FDA Product Classification

INGREDIENTS (9)

LIMONIA ACIDISSIMA BARKInactive
Code: 68SJ7W9Y65
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
ZINC OXIDEActive
Quantity: 25 g in 100 g
Code: SOI2LOH54Z
Classification: ACTIB
BABASSU OILInactive
Code: 8QSB4M5477
Classification: IACT
LECITHIN, SUNFLOWERInactive
Code: 834K0WOS5G
Classification: IACT
TALLOWInactive
Code: 98HPY76U4W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATEInactive
Code: D2QHA03458
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/29/2025

Packaging

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/29/2025

helps prevent sunburn; 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 - PURPOSE SECTION

LOINC: 55105-1Updated: 1/29/2025

Sunscreen

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/29/2025

Shake well before use.
Apply liberally 15 minutes before sun exposure.
Reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/29/2025

Aqua (Water), Tallow, Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Lecithin, Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate

WARNINGS SECTION

LOINC: 34071-1Updated: 1/29/2025

Warnings:
For external use only.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product, keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/29/2025

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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