ULTRA SOOTHER DRY-TOUCH SUNSCREEN- homosalate, octisalate, octocrylene, zinc oxide cream

ULTRA SOOTHER DRY-TOUCH SUNSCREEN by

Drug Labeling and Warnings

ULTRA SOOTHER DRY-TOUCH SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by skinnplus, COSMAX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

HOMOSALATE 5.19%
OCTISALATE 2.25%

OCTOCRYLENE 2.5%

ZINC OXIDE 3.0%

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

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

WARNINGS

For external use only

DO NOT USE

on damaged skin or broken skin

WHEN USING

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.

DOSAGE & ADMINISTRATION

■ apply liberally 15 minutes before sun exposure.

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

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

OTHER SAFETY INFORMATION

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

INACTIVE INGREDIENT

WATER, PROPANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, COCO-CAPRYLATE/CAPRATE, GLYCERIN, PENTYLENE GLYCOL, 1,2-HEXANEDIOL, CETEARYL OLIVATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, CETEARYL ALCOHOL, GLYCERYL STEARATE, LAUROYL LYSINE, POLYHYDROXYSTEARIC ACID, PANTHENOL, TRIETHOXYCAPRYLYLSILANE, ACRYLATES COPOLYMER, STEARIC ACID, TROMETHAMINE, SPHINGOMONAS FERMENT EXTRACT, NEOPENTYL GLYCOL DIETHYLHEXANOATE, ETHYLHEXYLGLYCERIN, POLYACRYLATE CROSSPOLYMER-6, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, BIOSACCHARIDE GUM-1, CITRIC ACID, ACETYL GLUCOSAMINE, SODIUM HYALURONATE, HYDROXYACETOPHENONE, SODIUM HYALURONATE CROSSPOLYMER, TOCOPHEROL, CAPRYLYL GLYCOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA SOOTHER DRY-TOUCH SUNSCREEN 
homosalate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87534-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.19 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
LAUROYL LYSINE (UNII: 113171Q70B)
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TROMETHAMINE (UNII: 023C2WHX2V)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ACETYL GLUCOSAMINE (UNII: V956696549)
CITRIC ACID (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87534-150-02	1 in 1 BOX	03/24/2026
1	NDC: 87534-150-01	50 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	03/24/2026

Labeler - skinnplus (694758646)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC.		689049693	manufacture(87534-150)