84326-424 Miffy Sunny Defense Spf Stick

84326-424 Miffy Sunny Defense Spf Stick
SPL v2
SPL
SPL Set ID 24802b17-c0ba-1075-e063-6394a90addd5
Route
TOPICAL
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.55 g) Homosalate (2.09 g) Octocrylene (0.99 g) Octisalate
Inactive Ingredients
1,2-hexanediol Water Butylene Glycol Hyaluronate Sodium Ethylhexyl Palmitate Ethylhexylglycerin Dicaprylyl Carbonate Butyloctyl Salicylate Tocopherol Dimethylsilanol Hyaluronate Allantoin Centella Asiatica Triterpenoids Sodium Acetylated Hyaluronate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-15

Description

Avobenzone 2.5% Homosalate 9.5% Octisalate 4.5% Octocrylene 9.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

● 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.

Dosage and Administration

Directions

● Apply liberally 15 minutes before sun exposure.

● Use a water resistant sunscreen if swimming or swating.

● Reapply at least every 2 hours.

● Children under 6 months of age: Ask a doctor.

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 other sun protection measures including: ● Limit time in the sun, especially from 10 a.m. - 2 p.m. ● Wear long-sleeve shirts, pants, hats, and sunglasses.

Description

Avobenzone 2.5% Homosalate 9.5% Octisalate 4.5% Octocrylene 9.5%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

and ask a doctor if rash occurs.

Section 50567-7

● Keep out of eyes. Rinse with water to remove.

Section 50570-1

● on damaed skin or broken skin

Section 51727-6

Ethylhexyl Palmitate, Synthetic Wax, Butyloctyl Salicylate, Dicaprylyl Carbonate, Ethylhexylglycerin, Water, Tocopherol, Allantoin, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Sodium Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

Section 60561-8

● Protect this product from excessive heat and direct sun.

Pdp Miffy Sunny Defense Spf Stick


Structured Label Content

Indications and Usage (34067-9)

● 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.

Dosage and Administration (34068-7)

Directions

● Apply liberally 15 minutes before sun exposure.

● Use a water resistant sunscreen if swimming or swating.

● Reapply at least every 2 hours.

● Children under 6 months of age: Ask a doctor.

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 other sun protection measures including: ● Limit time in the sun, especially from 10 a.m. - 2 p.m. ● Wear long-sleeve shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

● Keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

● on damaed skin or broken skin

Section 51727-6 (51727-6)

Ethylhexyl Palmitate, Synthetic Wax, Butyloctyl Salicylate, Dicaprylyl Carbonate, Ethylhexylglycerin, Water, Tocopherol, Allantoin, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Sodium Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

Section 60561-8 (60561-8)

● Protect this product from excessive heat and direct sun.

Pdp Miffy Sunny Defense Spf Stick (PDP_Miffy Sunny Defense SPF Stick)


Advanced Ingredient Data


Raw Label Data

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