Replenix®

Replenix®
SPL v1
SPL
SPL Set ID 37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4
Route
TOPICAL
Published
Effective Date 2024-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (165 mg) Titanium Dioxide (23 mg)
Inactive Ingredients
Acrylates Crosspolymer-4 Ascorbic Acid Biotin Butyrospermum Parkii (shea) Butter Unsaponifiables Green Tea Leaf Medium-chain Triglycerides Cetostearyl Alcohol Ceteth-10 Phosphate Cyclomethicone Dihexadecyl Phosphate Dimethicone Edetate Disodium Hexyl Laurate Isododecane Lauryl Peg/ppg-18/18 Methicone Lecithin, Sunflower Peg-10 Dimethicone (200 Cst) Phenoxyethanol Phyllanthus Emblica Fruit Polyhydroxystearic Acid (2300 Mw) Polymethylsilsesquioxane (11 Microns) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Potassium Cetyl Phosphate Potassium Hydroxide Water Resveratrol Stearic Acid Ubidecarenone Vitamin A Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-23
Description

Drug Facts

Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children.
  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9
  • Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
Section 50567-7
  • When using this product keep out of eyes, rinse with water to remove.
Section 55105-1
Active ingredient Purpose
Zinc Oxide 16.5% Sunscreen
Titanium Dioxide 2.3% Sunscreen
Warnings

For external use only.

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.
Inactive Ingredients

Acrylates Crosspolymer-4, Ascorbic Acid, Biotin, Butyrospermum Parkii Butter, Camellia Sinensis Leaf (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclomethicone, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Hexyl Laurate, Isododecane, Lauryl PEG/PPG-18/18 Methicone, Lecithin, PEG-10 Dimethicone, Phenoxyethanol, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polysilicone-11, Potassium Cetyl Phosphate, Potassium Hydroxide, Purified Water, Resveratrol, Stearic Acid, Ubiquinone (Coenzyme Q-10), Retinyl Palimtate, Xanthan Gum.

Principal Display Panel 60 G Bottle Label

REPLENiX®

SHEER PHYSICAL

SUNSCREEN

SPF

50+

CREAM

UVA UVB

BROAD SPECTRUM SPF 50+

  • Zinc Oxide 13.75%
  • Green Tea Polyphenols
  • Resveratrol
  • Vitamin C
  • Emblica
  • CoQ10

Net 2 fl. oz. (60 ml)

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701

Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children.
  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)
  • Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
Section 50567-7 (50567-7)
  • When using this product keep out of eyes, rinse with water to remove.
Section 55105-1 (55105-1)
Active ingredient Purpose
Zinc Oxide 16.5% Sunscreen
Titanium Dioxide 2.3% Sunscreen
Warnings

For external use only.

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.
Inactive Ingredients (Inactive ingredients)

Acrylates Crosspolymer-4, Ascorbic Acid, Biotin, Butyrospermum Parkii Butter, Camellia Sinensis Leaf (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclomethicone, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Hexyl Laurate, Isododecane, Lauryl PEG/PPG-18/18 Methicone, Lecithin, PEG-10 Dimethicone, Phenoxyethanol, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polysilicone-11, Potassium Cetyl Phosphate, Potassium Hydroxide, Purified Water, Resveratrol, Stearic Acid, Ubiquinone (Coenzyme Q-10), Retinyl Palimtate, Xanthan Gum.

Principal Display Panel 60 G Bottle Label (PRINCIPAL DISPLAY PANEL - 60 g Bottle Label)

REPLENiX®

SHEER PHYSICAL

SUNSCREEN

SPF

50+

CREAM

UVA UVB

BROAD SPECTRUM SPF 50+

  • Zinc Oxide 13.75%
  • Green Tea Polyphenols
  • Resveratrol
  • Vitamin C
  • Emblica
  • CoQ10

Net 2 fl. oz. (60 ml)

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:20.619385 · Updated: 2026-03-14T23:03:22.878855