ADVANCED DAY ULTIMATE PROTECT SUNSCREEN SPF 50- butyl methoxydibenzoylmethane, ethylhexyl salicylate cream

Advanced Day Ultimate Protect Sunscreen SPF 50 by

Drug Labeling and Warnings

Advanced Day Ultimate Protect Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Medik8 Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Butyl Methoxydibenzoylmethane 2.8% Sunscreen

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

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

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

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.

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

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

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)

INGREDIENTS AND APPEARANCE

ADVANCED DAY ULTIMATE PROTECT SUNSCREEN SPF 50 
butyl methoxydibenzoylmethane, ethylhexyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79988-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	4.8 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
BUTYL METHOXYDIBENZOYLMETHANE (UNII: G63QQF2NOX) (BUTYL METHOXYDIBENZOYLMETHANE - UNII:G63QQF2NOX)	BUTYL METHOXYDIBENZOYLMETHANE	2.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BERGAMOT OIL (UNII: 39W1PKE3JI)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRONELLOL (UNII: P01OUT964K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SQUALANE (UNII: GW89575KF9)
CARNOSINE (UNII: 8HO6PVN24W)
SILICA (UNII: ETJ7Z6XBU4)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
GLYCERIN (UNII: PDC6A3C0OX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ISODODECANE (UNII: A8289P68Y2)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIMETHICONE 20 (UNII: H8YMB5QY0D)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LINALOOL (UNII: D81QY6I88E)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GERANIOL (UNII: L837108USY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
GLYCERETH-26 (UNII: NNE56F2N14)
ECTOINE (UNII: 7GXZ3858RY)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
WATER (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL (UNII: 8U3877WD44)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79988-002-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/06/2025
2	NDC: 79988-002-05	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/06/2025

Labeler - Medik8 Limited (237907881)