THEOG- zinc oxide lotion

TheOG by

Drug Labeling and Warnings

TheOG by is a Otc medication manufactured, distributed, or labeled by Spooge, Sun Deep, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Zinc Oxide 22%
Purpose

Sunscreen
Uses
- 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

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.

Keep out of reach of children. In case of ingestion, get medical help or contact a poison control center. Children under 6 months of age- ask a doctor.
Directions
- Apply liberally 20 min before sun exposure and at least every two hours. Otherwise, use a water resistant sunscreen if swimming or sweating.
  Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including:
  - limit time in the sun, especially from 10am-2pm
  - wear long sleeved shirts, pants, hats and sunglasses
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients

Aloe Barbadensis Leaf Juice1, Sodium Hyaluronate, 3-O-Ethyl Ascorbic Acid, Bisabolol, Tocopherol, Lactobacillus Ferment, Inulin, Hydrolyzed Jojoba Esters, Water, Glycerin, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil1, Lysolecithin, Sclerotium Gum, Xanthan Gum, Pullulan, Glycolipids, Isoamyl Laurate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polyester-a, Cetearyl Alcohol, Coco-Glucoside, Glyceryl Stearate, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Sodium Stearoyl Glutamate, Citric Acid, Dimethicone, Glyceryl Caprylate, Caprylhydroxamic Acid, Fragrance (Sea Salt & Sage ORC2402697).

1 certified Organic Ingredient

SPL UNCLASSIFIED SECTION

Dist. by SPOOGE LLC.
3495 Lakeside Dr #255 Reno, NV 89509

PRINCIPAL DISPLAY PANEL - 148 mL Tube Box

The
OG

PROTECTION FOR
ALL YOUR PARTS

SHEER MINERAL ALL-SCREEN
WITH ALOE LEAF JUICE
+ VITAMINS C, E

50
FACE+ BODY SPF
BROAD SPECTRUM UVA/UVB

SPOOGE™

USE PROTECTION
DERMATOLOGIST DEVELOPED

5.0 FL OZ/ 148 ML

PRINCIPAL DISPLAY PANEL - 148 mL Tube Box

INGREDIENTS AND APPEARANCE

THEOG
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85385-468
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
JOJOBA OIL (UNII: 724GKU717M)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
XANTHAN GUM (UNII: TTV12P4NEE)
PULLULAN (UNII: 8ZQ0AYU1TT)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO-GLUCOSIDE (UNII: ICS790225B)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 85385-468-03	1 in 1 BOX	06/25/2025
1		148 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	06/25/2025

Labeler - Spooge (135771317)

Registrant - Sun Deep, Inc. (189788201)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Deep, Inc.		189788201	MANUFACTURE(85385-468)