Label: SUN CONTROL BROAD SPECTRUM SPF 30- homosalate, octisalate, zinc oxide cream
- NDC Code(s): 84259-475-00
- Packager: SKINPLAN.US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 15, 2024
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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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.
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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
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INGREDIENTS AND APPEARANCE
SUN CONTROL BROAD SPECTRUM SPF 30
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84259-475 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/22/2024 Labeler - SKINPLAN.US LLC (118741900)
