Theog

Theog
SPL v2
SPL
SPL Set ID a2f781a8-eba8-48f5-8680-9235aae8a4ff
Route
TOPICAL
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g)
Inactive Ingredients
Aloe Vera Leaf Juice Hyaluronate Sodium 3-o-ethyl Ascorbic Acid Levomenol Tocopherol Hydrolyzed Jojoba Esters (acid Form) Water Glycerin Squalane Jojoba Oil Betasizofiran Xanthan Gum Pullulan Isoamyl Laurate Butyloctyl Salicylate Medium-chain Triglycerides Cetostearyl Alcohol Coco-glucoside Glyceryl Monostearate Sorbitan Sesquioleate Sodium Stearoyl Glutamate Citric Acid Monohydrate Dimethicone, Unspecified Glyceryl Monocaprylate Caprylhydroxamic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-25

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For External Use Only

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.
Active Ingredients

Zinc Oxide 22%

Inactive Ingredients

Aloe Barbadensis Leaf Juice

certified Organic Ingredient
, Sodium Hyaluronate, 3-O-Ethyl Ascorbic Acid, Bisabolol, Tocopherol, Lactobacillus Ferment, Inulin, Hydrolyzed Jojoba Esters, Water, Glycerin, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil
, 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).

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


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings

For External Use Only

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 (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients (Active ingredients)

Zinc Oxide 22%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice

certified Organic Ingredient
, Sodium Hyaluronate, 3-O-Ethyl Ascorbic Acid, Bisabolol, Tocopherol, Lactobacillus Ferment, Inulin, Hydrolyzed Jojoba Esters, Water, Glycerin, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil
, 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).

Principal Display Panel 148 Ml Tube Box (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


Advanced Ingredient Data


Raw Label Data

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