SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone spray

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

HOMOSALATE 15%
OCTOCRYLENE 10%
OCTINOXATE 7.4%
OXYBENZONE 4%
AVOBENZONE 3%

Purpose

SUNSCREEN

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.

Warnings

For external use only.

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs

When using this product

keep out of eyes. Rinse with water to remove

Keep out of reach of children.

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

Flammable:

Keep away from fire or flame.

Avoid spraying in eyes.

Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F.

Directions

Apply liberally 15 minutes before sun exposure.
Shake well before use.
Do not spray directly into face. Spray on hands then apply to face.
Apply to all skin exposed to the sun
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
Children under 6 months: Ask a doctor.

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.

Other information

store at controlled room temperature 20°-25°C (68°-77°F). Protect from freezing and excessive heat over 40°C (104°F).

Inactive ingredients

BUTANE, PROPANE, ISOBUTANE, ALCOHOL DENAT., ISODODECANE, BUTYL OCTYL SALICYLATE, POLYMETHYLSILSESQUIOXANE, SILICA, BISABOLOL, MENTHYLLACTATE, METHYL DIISOPROPYL PROPIONAMIDE, METHICONE, BHT, CERAMIDE NP.

87467-001-01

INGREDIENTS AND APPEARANCE

SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87467-001
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MDMC (UNII: L4I4B1R01F)
BISABOLOL (UNII: 24WE03BX2T)
MENTHYL LACTATE (UNII: 2BF9E65L7I)
BUTANE (UNII: 6LV4FOR43R)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
BHT (UNII: 1P9D0Z171K)
PROPANE (UNII: T75W9911L6)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CERAMIDE NP (UNII: 4370DF050B)
ISOBUTANE (UNII: BXR49TP611)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SILICA (UNII: ETJ7Z6XBU4)
ISODODECANE (UNII: A8289P68Y2)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87467-001-01	1 in 1 CARTON	04/14/2026
1		250 g in 1 BOTTLE; 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	04/14/2026

Labeler - Gold Inti Trade Corporation (133616663)

Establishment
Name	Address	ID/FEI	Business Operations
Longway Technology(Guangzhou) Co., Ltd.		844528915	manufacture(87467-001)