TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUM- homosalate, avobenzone, octisalate, octocrylene lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 9%

Octocrylene 5%

Octisalate 4.5%

Avobenzone 3%

PURPOSE

Sunscreen

INSTRUCTIONS FOR USE

Uses

• Helps prevent sunburn.

WARNINGS

For external use only.

ASK DOCTOR

Stop use and ask a doctor if rash occurs.

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
• 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 value of 15 or higher and other sun protection measures including:
• limited 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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children If product is swallowed, get medical help or contact poison control center immediately.

OTHER SAFETY INFORMATION

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

QUESTIONS

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DO NOT USE

Do not use on damaged or broken skin.

INDICATIONS & USAGE

• 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 INGREDIENT

Water, Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Acrylates Copolymer, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Ceteareth-20, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance, Tromethamine, 1,2-Hexanediol, Isohexade cane, Tocopheryl Acetate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Propanediol, Butylene Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Polysorbate 80, Trisodium Ethylene diamine Disuccinate, Sorbitan Oleate, Xanthan Gum, Glycerin, Hydrolyzed Collagen, Hydrolyzed Hyaluronic Acid, Hyaluronic Acid, Sodium Hyaluronate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUM 
homosalate, avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87496-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SORBITAN OLEATE (UNII: 06XEA2VD56)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CETEARETH-20 (UNII: YRC528SWUY)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN STEARATE (UNII: NVZ4I0H58X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
PANTHENOL (UNII: WV9CM0O67Z)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TROMETHAMINE (UNII: 023C2WHX2V)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87496-201-01	1 in 1 BOX	03/01/2026
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 87496-201-02	1 in 1 BOX	03/01/2026
2		10 mL in 1 TUBE; 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	02/01/2026

Labeler - TIRTIR USA Inc. (134472449)