Advanced Day Ultimate Protect Sunscreen Spf 50

Advanced Day Ultimate Protect Sunscreen Spf 50
SPL v1
SPL
SPL Set ID 29071920-ba90-871a-e063-6294a90aee27
Route
TOPICAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Salicylate (4.8 g) Octocrylene (9.5 g) Homosalate (10 g) Butyl Methoxydibenzoylmethane (2.8 g)
Inactive Ingredients
Dehydroacetic Acid Bergamot Oil Lecithin, Soybean Ppg-12/smdi Copolymer Pelargonium Graveolens Flower Oil Limonene, (+)- Citronellol Butyloctyl Salicylate Potassium Cetyl Phosphate Squalane Carnosine Silica Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Glycerin Isodecyl Neopentanoate Isododecane Glyceryl Stearate Peg-100 Stearate Cetearyl Alcohol Neopentyl Glycol Diheptanoate Dimethicone 20 Dibutyl Adipate Propylene Glycol Dibenzoate Hydroxyacetophenone Ethylhexylglycerin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Linalool Citrus Limon (lemon) Peel Oil Sodium Hyaluronate Edetate Disodium Sodium Hydroxide Geraniol Phenoxyethanol Spirulina Maxima Glycereth-26 Ectoine Inulin Lauryl Carbamate Water Benzoic Acid Citrus Grandis (grapefruit) Peel Oil Citral

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06

Description

Active Ingredients Purpose Butyl Methoxydibenzoylmethane 2.8% Sunscreen Ethylhexyl Salicylate 4.8% ...................... Sunscreen Homosalate 10%..................................... Sunscreen Octocrylene 9.5%...................................... Sunscreen


Medication Information

Warnings and Precautions

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.
Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and 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

Description

Active Ingredients Purpose Butyl Methoxydibenzoylmethane 2.8% Sunscreen Ethylhexyl Salicylate 4.8% ...................... Sunscreen Homosalate 10%..................................... Sunscreen Octocrylene 9.5%...................................... Sunscreen

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Medik8

Advanced Day Ultimate Protect

Age-Defying Moisturizer

Sunscreen SPF 50+ with photolyase & Ectoin

Broad Spectrum SPF 50+

1.69 FL. OZ. (50 mL)

Section 55105-1

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 55106-9

Active Ingredients Purpose

Butyl Methoxydibenzoylmethane 2.8% Sunscreen

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

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

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

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Medik8

Advanced Day Ultimate Protect

Age-Defying Moisturizer

Sunscreen SPF 50+ with photolyase & Ectoin

Broad Spectrum SPF 50+

1.69 FL. OZ. (50 mL)

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active Ingredients Purpose

Butyl Methoxydibenzoylmethane 2.8% Sunscreen

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

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

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

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data


Raw Label Data

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