replenix®

replenix®
SPL v1
SPL
SPL Set ID 9223ffa8-7af3-4407-9170-482afec536d8
Route
topical
Published
Effective Date 2023-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (145 mg) octinoxate (75 mg)
Inactive Ingredients
water niacinamide oleth-3 phosphate neopentyl glycol diheptanoate octyldodecyl neopentanoate butylene glycol .alpha.-tocopherol acetate hyaluronate sodium caffeine panthenol dimethicone sucrose lactic acid, dl- glycerin ethylhexyl stearate triethoxycaprylylsilane xanthan gum peg-7 trimethylolpropane coconut ether phenoxyethanol edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-10-16

Description

Drug Facts


Medication Information

Warnings

For external use only.

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.
Directions
  • Apply liberally to face and neck and spread evenly 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

Purified Water, Niacinamide, Oleth-3 Phosphate, Neopentyl Glycol Diheptanoate, Polyisobutene, Octyldodecyl Neopentanoate, Butylene Glycol, Tocopheryl Acetate, Sodium Hyaluronate, Caffeine, Panthenol, Dimethicone, Sucrose, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilane, Xanthan Gum, Lauryl PEG Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Phenoxyethanol, Disodium EDTA.

Description

Drug Facts

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 14.5% Sunscreen
Octinoxate 7.5% Sunscreen
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
Principal Display Panel 63 G Bottle Label

REPLENiX®

SUNSCREEN

ESSENTIAL

OIL FREE SHEER

SPF 50

14.5% Micronized Zinc Oxide

Multi-tasking sheer application

Sensitive skin friendly

BROAD SPECTRUM UVA/UVB SPF 50

Net wt. 2.22 oz. (63 g)

TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701


Structured Label Content

Warnings

For external use only.

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.
Directions
  • Apply liberally to face and neck and spread evenly 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)

Purified Water, Niacinamide, Oleth-3 Phosphate, Neopentyl Glycol Diheptanoate, Polyisobutene, Octyldodecyl Neopentanoate, Butylene Glycol, Tocopheryl Acetate, Sodium Hyaluronate, Caffeine, Panthenol, Dimethicone, Sucrose, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilane, Xanthan Gum, Lauryl PEG Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Phenoxyethanol, Disodium EDTA.

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 14.5% Sunscreen
Octinoxate 7.5% Sunscreen
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
Principal Display Panel 63 G Bottle Label (PRINCIPAL DISPLAY PANEL - 63 g Bottle Label)

REPLENiX®

SUNSCREEN

ESSENTIAL

OIL FREE SHEER

SPF 50

14.5% Micronized Zinc Oxide

Multi-tasking sheer application

Sensitive skin friendly

BROAD SPECTRUM UVA/UVB SPF 50

Net wt. 2.22 oz. (63 g)

TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)