Moisturizing Morning Cream Spf 15

Moisturizing Morning Cream Spf 15
SPL v3
SPL
SPL Set ID 9903084e-a5c0-455d-b56c-4f0bd7634303
Route
TOPICAL
Published
Effective Date 2023-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5.0 g) Octisalate (2.0 g)
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate Medium-chain Triglycerides Niacinamide Cetearyl Olivate Cetyl Alcohol Water Sorbitan Olivate Hyaluronate Sodium Silicon Dioxide Argan Oil Glycerin Glyceryl Monostearate Polyglyceryl-10 Laurate Phenoxyethanol Caprylyl Glycol Dimethicone Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Sodium Stearoyl Glutamate Ethyl Ferulate Ethylhexylglycerin Castor Oil Coconut Oil Opuntia Ficus-indica Seed Oil Grape Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-18

Description

DRUG FACTS Active Ingredients Octocrylene 5% Octisalate 2%


Medication Information

Warnings and Precautions

Warnings • Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of

skin cancer and early skin aging. This product has been shown to only help prevent sunburn,

not skin cancer or early skin aging. • 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.

Indications and Usage

Uses: Helps prevent sunburn.

Dosage and Administration

Directions • Apply generously 15 minutes before sun exposure. • Use in the morning.

• Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub

cream gently into your face and neck, avoiding the eyes.

Description

DRUG FACTS Active Ingredients Octocrylene 5% Octisalate 2%

Section 50565-1

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

Section 51727-6

Inactive Ingredients   Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Caprylic/Cap-

ric Triglyceride, Niacinamide, Cetearyl Olivate, Cetyl Alcohol, Water (Aqua/Eau), Sorbitan Olivate,

Sodium Hyaluronate, Silica, Argania Spinosa Kernel Oil, Glycerin, Glyceryl Stearate,

Polyglyceryl-10 Laurate, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Polyacrylate

Crosspolymer-6, Sodium Stearoyl Glutamate, Ethyl Ferulate, Ethylhexylglycerin, Ricinus Com-

munis (Castor) Seed Oil, Cocos Nucifera (Coconut) Oil, Opuntia Ficus-Indica Seed Oil, Vitis Vini-

fera (Grape) Seed Oil

Section 55105-1

Purpose .... Sunscreem

Section 55106-9

DRUG FACTS

Active Ingredients

Octocrylene 5%

Octisalate 2%

Section 60561-8

Other information • Protect the product in this container from excessive heat and direct sun.

Product Labeling

Moisturizing Morning Cream

SPF 15

Distributed by Geologie

2578 Broadway #A212

New York, NY 10025

20 ml .67 fl oz

20 mL Label

60 mL Label

res


Structured Label Content

Indications and Usage (34067-9)

Uses: Helps prevent sunburn.

Dosage and Administration (34068-7)

Directions • Apply generously 15 minutes before sun exposure. • Use in the morning.

• Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub

cream gently into your face and neck, avoiding the eyes.

Warnings and Precautions (34071-1)

Warnings • Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of

skin cancer and early skin aging. This product has been shown to only help prevent sunburn,

not skin cancer or early skin aging. • 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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients   Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Caprylic/Cap-

ric Triglyceride, Niacinamide, Cetearyl Olivate, Cetyl Alcohol, Water (Aqua/Eau), Sorbitan Olivate,

Sodium Hyaluronate, Silica, Argania Spinosa Kernel Oil, Glycerin, Glyceryl Stearate,

Polyglyceryl-10 Laurate, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Polyacrylate

Crosspolymer-6, Sodium Stearoyl Glutamate, Ethyl Ferulate, Ethylhexylglycerin, Ricinus Com-

munis (Castor) Seed Oil, Cocos Nucifera (Coconut) Oil, Opuntia Ficus-Indica Seed Oil, Vitis Vini-

fera (Grape) Seed Oil

Section 55105-1 (55105-1)

Purpose .... Sunscreem

Section 55106-9 (55106-9)

DRUG FACTS

Active Ingredients

Octocrylene 5%

Octisalate 2%

Section 60561-8 (60561-8)

Other information • Protect the product in this container from excessive heat and direct sun.

Product Labeling

Moisturizing Morning Cream

SPF 15

Distributed by Geologie

2578 Broadway #A212

New York, NY 10025

20 ml .67 fl oz

20 mL Label

60 mL Label

res


Advanced Ingredient Data


Raw Label Data

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