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Sky and Sol Face Sunscreen SPF 50

Approved
Approval ID

2de875d8-4211-3811-e063-6394a90a4f72

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 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.

Non-Nano Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84632-5050
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Non-Nano Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 19, 2025
FDA Product Classification

INGREDIENTS (10)

.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
HYDROLYZED JOJOBA ESTERSInactive
Code: UDR641JW8W
Classification: IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATEInactive
Code: D2QHA03458
Classification: IACT
TALLOWInactive
Code: 98HPY76U4W
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LECITHIN, SUNFLOWERInactive
Code: 834K0WOS5G
Classification: IACT
ZINC OXIDEActive
Quantity: 25 g in 100 g
Code: SOI2LOH54Z
Classification: ACTIB
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Code: 724GKU717M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Packaging

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/4/2025

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

WARNINGS SECTION

LOINC: 34071-1Updated: 1/4/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/4/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/4/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/4/2025

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: 1/31/2025

Sunscreen

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Sky and Sol Face Sunscreen SPF 50 - FDA Drug Approval Details