STRYX DAILY MOISTURIZER SPF-30- octisalate, ensulizole cream

STRYX Daily Moisturizer SPF-30 by

Drug Labeling and Warnings

STRYX Daily Moisturizer SPF-30 by is a Otc medication manufactured, distributed, or labeled by STRYX MEN, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octisalate 5.00%

Phenylbenzimidazole Sulfonic Acid 4.00%

Purpose

Sunscreen

Uses:

- Helps prevent sunburn

- Higher SPF gives more sunburn protection

- 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

Warnings:

For external use only not intended for ingestion

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

i rash or irritation develops and lasts

Keep out of reach of children

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

Directions:

- Apply liberally 15 minutes before sun exposure

- Children under 6 months of age: ask a doctor 

- Reapply: at least every 2 hours

- Sun Protection Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

1. Limit time in the sun, especially from 10 a.m.- 2 p.m.
2. Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:

- Protect the product in this container from excessive heat and direct sun

Inactive Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bisabalol, Butyl Methoxydibenzoylmethane, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Hydrolyzed Oat Protein, Malus Domestica (Apple) Fruit Cell Culture Extract, Olea Europaea (Olive) Oil, Palmitoyl Tripeptide-5, Pentylene GLycol, Phenoxyethanol, Phenylethyl Resorcinol, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum

Package Labeling:

INGREDIENTS AND APPEARANCE

STRYX DAILY MOISTURIZER SPF-30 
octisalate, ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82281-239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
LEVOMENOL (UNII: 24WE03BX2T)
AVOBENZONE (UNII: G63QQF2NOX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYALURONIC ACID (UNII: S270N0TRQY)
APPLE (UNII: B423VGH5S9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82281-239-00	100 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/10/2021

Labeler - STRYX MEN, INC. (083655323)