Advanced Day Ultimate Protect Sunscreen Spf 50 Cream
FDA Label NDC 79988-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medik8 Limited for the product Advanced Day Ultimate Protect Sunscreen Spf 50 (NDC 79988-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Otc - Keep Out Of Reach Of Children

→ Indications & Usage

→ Warnings

→ Dosage & Administration

→ Other Safety Information

→ Inactive Ingredient

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredients Purpose

Butyl Methoxydibenzoylmethane 2.8% Sunscreen

Ethylhexyl Salicylate 4.8% ...................... Sunscreen

Homosalate 10%..................................... Sunscreen

Octocrylene 9.5%...................................... Sunscreen

Otc - Purpose

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.

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop use and ask a doctor if rash occurs.

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.

Dosage & Administration

Directions

Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
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 with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. -2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: Ask a doctor

Other Safety Information

Other information

Protect the product in this container for excessive heat and direct sun.

Inactive Ingredient

Inactive ingredients

Water, Butyloctyl Salicylate, Dibutyl Adipate, Glycerin, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Dimethicone, Isododecane, Glycereth-26, Glyceryl Steareate, PEG-100 Stearate, Cetearyl Alcohol, Potassium Cetyl Phosphate, PPG-12/SMDI Copolymer, Silica, Squalane, Sodium Hyaluronate Propylene Glycol Dibenzoate, Polysilicone-11, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Ectoin, Hydroxyacetophenone, Inulin Lauryl Carbamate, Disodium EDTA, Benzoic Acid, Sodium Hydroxide, Spirulina Maxima Extract, Dehydroacetic Acid, Carnosine, Citrus Grandis (Grapefruit) Peel Oil, Phenoxyethanol, Ethylhexylglycerin, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Limon (Lemon) Peel Oil, Lecithin, Pelargonium Graveolens (Geranium) Flower Oil, Limonene, Citronellol, Linalool, Geraniol, Citral

Package Label.Principal Display Panel

Medik8

Advanced Day Ultimate Protect

Age-Defying Moisturizer

Sunscreen SPF 50+ with photolyase & Ectoin

Broad Spectrum SPF 50+

1.69 FL. OZ. (50 mL)

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