Indications and 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.
Replenix Sheer
- Manufacturer
- Topiderm, Inc.
- Effective date
- 2024-07-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:16:11
Label at a glance#
ProductReplenix Sheer SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections
Dosage and administration
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.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredient | Purpose |
|---|---|
| Zinc Oxide 16.5% | Sunscreen |
| Titanium Dioxide 2.3% | 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.
OTC - WHEN USING SECTION
- When using this product keep out of eyes, rinse with water to remove.
OTC - STOP USE SECTION
- Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep out of reach of children.
- In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
SPL UNCLASSIFIED SECTION
- 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 10a.m.-2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51326-858-01 | Replenix SheerSPF 50 | 60 g in 1 BOTTLE, PLASTIC | CREAM | 60 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Replenix Sheer SPF 50
- Zinc Oxide Titanium Dioxide
- ZINC OXIDE
- TITANIUM DIOXIDE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51326-858 | 51326-858-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Replenix Sheer SPF 50 | ZINC OXIDE TITANIUM DIOXIDE | Topiderm, Inc. | 37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4 | 2024-07-29 | Warnings | 51326-858-01 51326-858 51326085801 1abf4f5e-ecc6-41c4-9bfb-617ad5a786fd 37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.