MOISTURIZING ANTIOXIDANT SPF 50- octinoxate, octisalate, homosalate, oxybenzone, zinc oxide spray

Moisturizing Antioxidant by

Drug Labeling and Warnings

Moisturizing Antioxidant 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
Octinoxate 7.5%	Sunscreen
Octisalate 5.0%	Sunscreen
Homosalate 7.0%	Sunscreen
Oxybenzone 5.0%	Sunscreen
Zinc Oxide 6.0%	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.

Directions

Apply liberally 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

Bisabolol, Caffeine, Camellia Sinensis (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetyl Phosphate, Cucumis Sativus (Cucumber) Fruit Extract, C13-14 Iso-Paraffin, Dimethicone, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phosphates, Ectoin, Ethylene Brassylate, Glycerin, Glyceryl Stearate, Laureth-7, PEG-12 Dimethicone, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-60, Silybum (Silymarin) Marianum Fruit Extract, Sodium Hyaluronate, Squalane, Sorbic Acid, Triethoxycaprylylsilane, Water, Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 120 ml Can Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

DAILY

Moisturizing
Antioxidant Sunscreen
SPF 50+

Broad Spectrum SPF 50+

Net 4 fl. oz. (120 ml)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

INGREDIENTS AND APPEARANCE

MOISTURIZING ANTIOXIDANT  SPF 50
octinoxate, octisalate, homosalate, oxybenzone, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-879
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CAFFEINE (UNII: 3G6A5W338E)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CUCUMBER (UNII: YY7C30VXJT)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
DIMETHICONE 200 (UNII: RGS4T2AS00)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM LAURIMINODIPROPIONATE (UNII: KAS63U0A87)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
ECTOINE (UNII: 7GXZ3858RY)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-7 (UNII: Z95S6G8201)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
PEG-100 MONOSTEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MILK THISTLE (UNII: U946SH95EE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
SORBIC ACID (UNII: X045WJ989B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-879-01	120 mL in 1 CANISTER; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	01/01/2020

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	MANUFACTURE(51326-879)