EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUS- avobenzone, homosalate, octisalate, octocrylene stick

EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUS by

Drug Labeling and Warnings

EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUS by is a Otc medication manufactured, distributed, or labeled by EADEM, Inc., COSMAX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - Active Ingredient Section

Active ingredients

Avobenzone (2.8%, Homosalate (6.5%)
Octisalate (4.5%), Octocrylene (6.5%)

OTC - Ask Doctor Section

* Stop use and ask a doctor if rash occurs

DO NOT USE

* Do not use on damaged or broken skin

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.

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

QUESTIONS

Questions * Email hello@eadem.co

WHEN USING

* When using this product, keep out of eyes. Rinse with water to remove

OTHER SAFETY INFORMATION

Warnings

* For external use only

* Do not use on damaged or broken skin

Dosage & Administration

For Sunscreen Use: * Apply liberally and evenly 15 minutes before sun exposure, using multiple back and forth passes to ensure complete coverage to the area of application, especially to the areas above the lip, nose, and tops of ears. * Reapply at least every 2 hours

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

* Stop use and ask a doctor if rash occurs

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

Inactive ingredients

Inactive ingredients

diethylhexyl carbonate, dimethicone, synthetic wax, methyl methacrylate crosspolymer, butyloctyl salicylate, diphenylsiloxy phenyl trimethicone, C12-15 alkyl benzoate, isopropyl palmitate, diisostearyl malate, ethylhexyl isononanoate, isoeicosane, polyethylene, polymethylsilesquioxane, ethylene/propylene copolymer, dimethicone/vinyl dimethicone crosspolymer, camellia japonica seed oil, bis-behenyl/isostearyl/phytosteryl dimer dilinoleyl dimer dilinoleate, ananas sativus (pineapple) fruit extract, carica papaya (papaya) fruit extract, garcinia mangostana peel extract, mangifera indica (mango) fruit extract, morinda citrifolia extract, musa sapientum (banana) fruit extract, nephelium lappaceum branch/fruit/leaf extract, psidium guajava fruit extract, resveratrol, zinc PCA, kaolin, zeolite, aluminum starch octenylsuccinate, caprylic/capric triglyceride, polyglyceryl-2 triisostearate, silica dimethyl silylate, dimethicone crosspolymer, blue 1 lake, yellow 5 lake

Indications & Usage

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

Package Label PDP for EADEM Sunsuede Daily Sunscreen & Blurring Primer SPF 50+

EADEM SUNSUEDE DAILY SUNSCREEN & BLURRING PRIMER SPF 50+ BROAD SPECTRUM

20 g (0.70 Fl.OZ.)

INGREDIENTS AND APPEARANCE

EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUS 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87486-100
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MANGO (UNII: I629I3NR86)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
CARICA PAPAYA (PAPAYA) FRUIT (UNII: KU94FIY6JB)
BANANA (UNII: 4AJZ4765R9)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
NEPHELIUM LAPPACEUM FRUIT (UNII: 2J089U1OXI)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GARCINIA MANGOSTANA FRUIT RIND (UNII: 1340BFH77T)
ANANAS SATIVUS (PINEAPPLE) FRUIT (UNII: 2A88ZO081O)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
DIMETHICONE 1000 (UNII: MCU2324216)
DIMETHICONE CROSSPOLYMER (450000 MPA.S) (UNII: UF7620L1W6)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DIISOSTEARYL MALEATE (UNII: 587Z76E9M5)
ISOEICOSANE (UNII: AR294KAG3T)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
BIS-BEHENYL/ISOSTEARYL/PHYTOSTERYL DIMER DILINOLEYL DIMER DILINOLEATE (UNII: G27BTQ95MJ)
GUAVA JUICE (UNII: 6T0W75Q603)
RESVERATROL (UNII: Q369O8926L)
ZINC PIDOLATE (UNII: C32PQ86DH4)
KAOLIN (UNII: 24H4NWX5CO)
ZEOLITE A (UNII: Y3NG9WF08W)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87486-100-01	1 in 1 CARTON	04/02/2026
1	NDC: 87486-100-02	20 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/02/2026

Labeler - EADEM, Inc. (118966588)

Registrant - EADEM, Inc. (118966588)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, Inc.		689049693	manufacture(87486-100)