mineral repair spf 45

mineral repair spf 45
SPL v3
SPL
SPL Set ID 84580f10-3119-4253-87a6-53d24a1f2227
Route
topical
Published
Effective Date 2023-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (150 mg)
Inactive Ingredients
allantoin bromelains alkyl (c12-15) benzoate c30-45 alkyl methicone c30-45 olefin green tea leaf dimethicone glyceryl monobehenate hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer isodecyl neopentanoate isononyl isononanoate isostearic acid papain phenoxyethanol phenyl trimethicone polyhydroxystearic acid (2300 mw) silicon dioxide .alpha.-tocopherol trimethylsiloxysilicate (m/q 1.0-1.2)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-05-07

Purpose

Sunscreen

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.
Purpose

Sunscreen

Directions

Apply liberally 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.
  • 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
Inactive Ingredients

Allantoin, Bromelain, C12-15 Alkyl Benzoate, C30-45 Alkyl Methicone, C30-45 Olefin, Camellia Sinensis (Green Tea) Polyphenols, Dimethicone, Glyceryl Behenate, HDI/Trimethylol Hexyllactone Crosspolymer, Isodecyl Neopentanoate, Isononyl Isononanoate, Isostearic Acid, Papain, Phenoxyethanol, Phenyl Trimethicone, Polyhydroxystearic Acid, Silica, Tocopherol, Trimethylsiloxysilicate.

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.

Active Ingredient

Zinc Oxide 15%

Principal Display Panel 30 G Bottle Label

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Sheer Mineral

Repair SPF 45

Broad Spectrum SPF 45

UVA/UVB Sunscreen

Water Resistant (80 min)

Net wt. 1 oz. (30 g)

Available

Custom Branded

800.445.2595

[email protected]


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.
Purpose

Sunscreen

Directions

Apply liberally 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.
  • 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
Inactive Ingredients (Inactive ingredients)

Allantoin, Bromelain, C12-15 Alkyl Benzoate, C30-45 Alkyl Methicone, C30-45 Olefin, Camellia Sinensis (Green Tea) Polyphenols, Dimethicone, Glyceryl Behenate, HDI/Trimethylol Hexyllactone Crosspolymer, Isodecyl Neopentanoate, Isononyl Isononanoate, Isostearic Acid, Papain, Phenoxyethanol, Phenyl Trimethicone, Polyhydroxystearic Acid, Silica, Tocopherol, Trimethylsiloxysilicate.

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.

Active Ingredient (Active ingredient)

Zinc Oxide 15%

Principal Display Panel 30 G Bottle Label (PRINCIPAL DISPLAY PANEL - 30 g Bottle Label)

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Sheer Mineral

Repair SPF 45

Broad Spectrum SPF 45

UVA/UVB Sunscreen

Water Resistant (80 min)

Net wt. 1 oz. (30 g)

Available

Custom Branded

800.445.2595

[email protected]


Advanced Ingredient Data


Raw Label Data

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