Essential Moisturizing Sunscreen

Essential Moisturizing Sunscreen
SPL v4
SPL
SPL Set ID 450d916e-4c77-489e-86b1-78b686355476
Route
TOPICAL
Published
Effective Date 2023-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (148 mg) Octinoxate (75 mg)
Inactive Ingredients
Water Diethylhexyl Succinate Octyldodecyl Neopentanoate Cetearyl Glucoside Cetyl Ethylhexanoate Polyisobutylene (2300 Mw) Hyaluronate Sodium .alpha.-tocopherol Acetate Caffeine Xanthan Gum 1,3-butanedithiol Triethoxycaprylylsilane Oleth-3 Phosphate Ethylhexyl Stearate Dimethicone Sucrose Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Peg-7 Trimethylolpropane Coconut Ether Panthenol Phenoxyethanol Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-09
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 14.8% Sunscreen
Octinoxate 7.5% Sunscreen
Warnings

For external use only.

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, Diethylhexyl Succinate, Octyldodecyl Neopentanoate, Cetearyl Glucoside, Cetyl Ethylhexanoate, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Xanthan Gum, Butylene Glycol, Triethoxycaprylylsilane, Oleth-3 Phosphate, Ethylhexyl Stearate, Dimethicone, Sucrose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-7 Trimethylolpropane Coconut Ether, Panthenol, Phenoxyethanol, Disodium EDTA.

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

MOISTURIZING

SPF 50

14.8% Micronized Zinc Oxide

Hydrating Hyaluronic Acid

Quick-absorbing Application

BROAD SPECTRUM UVA/UVB SPF 50

Net wt. 2.22 oz. (63 g)

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 14.8% Sunscreen
Octinoxate 7.5% Sunscreen
Warnings

For external use only.

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, Diethylhexyl Succinate, Octyldodecyl Neopentanoate, Cetearyl Glucoside, Cetyl Ethylhexanoate, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Xanthan Gum, Butylene Glycol, Triethoxycaprylylsilane, Oleth-3 Phosphate, Ethylhexyl Stearate, Dimethicone, Sucrose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-7 Trimethylolpropane Coconut Ether, Panthenol, Phenoxyethanol, Disodium EDTA.

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

MOISTURIZING

SPF 50

14.8% Micronized Zinc Oxide

Hydrating Hyaluronic Acid

Quick-absorbing Application

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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.985269 · Updated: 2026-03-14T23:04:15.032207