Drug Facts

Active ingredients

Homosalate 7%,

Octisalate 5%,

Zinc oxide 6%

Purpose

Sunscreen

Uses

Helps to 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.

• 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 last.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions

Apply liberally 15 minutes before sun exposure and as needed.
Children under 6 months of age: ask a doctor.
Reapply at least every 2 hours
Use 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 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.

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isododecane, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Teprenone, Tocopherol (Vitamin E), Tridecyl Salicylate, Trimethylsiloxysilicate.

Other information

Protect this product from excessive heat and direct sun.
May stain or damage some fabrics, materials or surfaces.

Questions or comments?

Call 216-245-8689

Package Labelling:

SUN CONTROL BROAD SPECTRUM SPF 30
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:84259-475
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 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	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT (UNII: L56Z1JK48B)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ISODODECANE (UNII: A8289P68Y2)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
TEPRENONE (UNII: S8S8451A4O)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:84259-475-00	1 in 1 BOX	04/22/2024
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/22/2024

Labeler - SKINPLAN.US LLC (118741900)

SUN CONTROL BROAD SPECTRUM SPF-30