HYBRID SPF SPF 30- octocrylene, octisalate, zinc oxide spray

Hybrid SPF by

Drug Labeling and Warnings

Hybrid SPF by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octocrylene 8.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Zinc Oxide 5.00%	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.

When using this product keep out of eyes, rinse with water to remove.

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Do not use on damaged or broken skin.

Directions

• Apply liberally and spread evenly by hand 15 minutes before sun exposure
• Re-apply after swimming, excessive perspiring, or anytime after towel drying
• Use a water resistant sunscreen if swimming or sweating
• Use on children under 6 months of age: consult 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 of 15 or higher and other sunscreen measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Adansonia Digitata (Baobab) Oil, Allantoin, 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, Carthamus Tinctorius (Safflower) Oil, Cetereth-20, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Glyceryl Laurate, Glyceryl Stearate SE, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Glycerin, Niacinamide, Polyhydroxystearic Acid, Polysorbate-20, Sorbitan Stearate, Tapioca Starch, Tocopherol (Vitamin E), Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 177 ml Can Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

DAILY

Sheer UV Protection
Sunscreen Spray
SPF 30

Broad Spectrum SPF 30
Water Resistant 80 Minutes
Fragrance Free
Aloe Vera
Green Tea

Net 6 fl. oz. (177 ml)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

INGREDIENTS AND APPEARANCE

HYBRID SPF  SPF 30
octocrylene, octisalate, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SAFFLOWER OIL (UNII: 65UEH262IS)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT JUICE (UNII: QXF936IX43)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STARCH, TAPIOCA (UNII: 24SC3U704I)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-128-01	177 mL in 1 CAN; Type 0: Not a Combination Product	10/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	10/07/2024

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	MANUFACTURE(51326-128)