Label: BROAD SPECTRUM SPF45- zinc oxide, octinoxate gel
- NDC Code(s): 39765-035-01
- Packager: Neutraderm, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 22, 2020
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- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions • Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician.
Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying at least every 2 hours.
Precautions • 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 value of SPF 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. Children under 6 months of age: Ask a physician.
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF45
zinc oxide, octinoxate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:39765-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) NIACINAMIDE (UNII: 25X51I8RD4) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) HYALURONATE SODIUM (UNII: YSE9PPT4TH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:39765-035-01 57 g in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/06/2020 Labeler - Neutraderm, Inc. (146224444) Establishment Name Address ID/FEI Business Operations Neutraderm, Inc. 146224444 manufacture(39765-035)
