YOUTH CORRIDOR SOOTHE AND DEFEND SPF-30- octocrylene, octisalate, zinc oxide cream

YOUTH CORRIDOR Soothe and Defend SPF-30 by

Drug Labeling and Warnings

YOUTH CORRIDOR Soothe and Defend SPF-30 by is a Otc medication manufactured, distributed, or labeled by Youth Corridor. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octocrylene 8.00%

Octisalate 5.00%

Zinc Oxide 3.00%

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 externel 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 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.
• Reapply as needed or after towel drying, swimming, or sweating
• Use a water-resistant sunscreen if swimming or sweating.
• 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: Sun Protection Measures:
• limit time in the sun, especially from 10a.m. - 2.p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Camellia Sinesis (Green Tea)Extract, Cetyl Alcohol, Cucumis Sativus (Cuumber) Extract, Dimethicone, Dodecane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuss(Sunflower)Oil, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Prunus Amygdalus, Dulcis (Almond)Oil, Stearic Acid, Tocopherol Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol.

Other information:

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

Questions?

Call (646) 449-8000; or info@youthcorridor.com

Package Labeling:

INGREDIENTS AND APPEARANCE

YOUTH CORRIDOR SOOTHE AND DEFEND SPF-30 
octocrylene, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81201-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETYL ALCOHOL (UNII: 936JST6JCN)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHICONE (UNII: 92RU3N3Y1O)
DODECANE (UNII: 11A386X1QH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALMOND (UNII: 3Z252A2K9G)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81201-111-00	60 mL in 1 CYLINDER; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2020

Labeler - Youth Corridor (021181182)