Ptr Max Mineral Naked Spf 45 - DailyMed Details

Ptr Max Mineral Naked Spf 45

SPL v3

SPL

SPL Set ID 0980992c-6488-2fa1-e063-6294a90a41ea

Route

TOPICAL

Published

Effective Date 2021-02-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (9.271756 g) Titanium Dioxide (0.9276575 g)

Inactive Ingredients

Triethoxycaprylylsilane Mica C9-12 Alkane Carthamus Tinctorius Seed Oleosomes Stearyl Phosphate Sodium Benzoate Isopropyl Titanium Triisostearate Isodecyl Neopentanoate Coco-caprylate/caprate Glyceryl Monostearate Cetyl Alcohol Phenoxyethanol Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Silicon Dioxide Diamond Phytate Sodium Ferric Oxide Yellow Polyhydroxystearic Acid (2300 Mw) Ferrosoferric Oxide .alpha.-tocopherol Acetate Xanthan Gum Polymethylsilsesquioxane (4.5 Microns) Ferric Oxide Red Potassium Sorbate Ethylhexyl Olivate Oleth-3 Phosphate Butyloctyl Salicylate Dicaprylyl Carbonate Peg-100 Stearate Cetearyl Olivate Propanediol Water Sorbitan Olivate Aluminum Oxide Squalane Gluconolactone Hydrogen Dimethicone (13 Cst) Ascorbic Acid

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-02-15

Description

Titanium Dioxide I.93% Zinc Oxide 19.24%

Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and aska doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Uses

helps prevent sunburn

lf used as directed with other sun protection measures

(see Directions), decreases the risk of skin cancer and early skinaging caused by the sun

Dosage and Administration

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water•resistant sunscreen if swimming or sweating

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 sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m.

wear long•sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: ask a doctor

Description

Titanium Dioxide I.93% Zinc Oxide 19.24%

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Ingredients

Water, Butyloctyl Salicylate, C9- 12 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, lsodecyl Neopentanoate, Dicaprylyl Carbonate, Cetyl Alcohol, Coco-Caprylate/ Caprate, Propanediol, Ethylhexyl Olivate, Glyceryl Stearate, PEG-I00 Stearate, Cetearyl Olivate, Stearyl Phosphate, Triethoxycaprylylsilane, Phenoxyethanol, Oleth•3 Phosphate, Sorbitan Olivate, HDI/Trimethylol Hexyllactone Crosspolymer, Alumina, Xanthan Gum, Polymethylsilsesquioxane, Polyhydroxystearic Acid, Squalane, Gluconolactone, Sodium Phytate, lsopropyl Titanium Triisostearate, Sodium Benzoate, Hydrogen Dimethicone, Potassium Sorbate, Silica, Tocopheryl Acetate, Ascorbic Acid, Diamond Powder, Iron Oxides, Mica

Section 51945-4

Section 53413-1

Question or comments?

Call toll free 1-800-PTR-SKIN (787-7546)

Section 55105-1

Active Ingredients.............................................................. Purpose

Titanium Dioxide I.93%................................................... Sunscreen

Zinc Oxide 19.24%..... ................................................... Sunscreen

Section 55106-9

Titanium Dioxide I.93%

Zinc Oxide 19.24%

Structured Label Content

Indications and Usage (34067-9)

Uses

helps prevent sunburn

lf used as directed with other sun protection measures

(see Directions), decreases the risk of skin cancer and early skinaging caused by the sun

Dosage and Administration (34068-7)

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water•resistant sunscreen if swimming or sweating

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 sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m.

wear long•sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and aska doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Butyloctyl Salicylate, C9- 12 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, lsodecyl Neopentanoate, Dicaprylyl Carbonate, Cetyl Alcohol, Coco-Caprylate/ Caprate, Propanediol, Ethylhexyl Olivate, Glyceryl Stearate, PEG-I00 Stearate, Cetearyl Olivate, Stearyl Phosphate, Triethoxycaprylylsilane, Phenoxyethanol, Oleth•3 Phosphate, Sorbitan Olivate, HDI/Trimethylol Hexyllactone Crosspolymer, Alumina, Xanthan Gum, Polymethylsilsesquioxane, Polyhydroxystearic Acid, Squalane, Gluconolactone, Sodium Phytate, lsopropyl Titanium Triisostearate, Sodium Benzoate, Hydrogen Dimethicone, Potassium Sorbate, Silica, Tocopheryl Acetate, Ascorbic Acid, Diamond Powder, Iron Oxides, Mica

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question or comments?

Call toll free 1-800-PTR-SKIN (787-7546)

Section 55105-1 (55105-1)

Active Ingredients.............................................................. Purpose

Titanium Dioxide I.93%................................................... Sunscreen

Zinc Oxide 19.24%..... ................................................... Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide I.93%

Zinc Oxide 19.24%

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)", "unii": "59Z907ZB69", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL OLIVATE", "unii": "HTC7G3S2PV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLETH-3 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"strengthDenominatorUnit": ""}, {"name": "GLUCONOLACTONE", "unii": "WQ29KQ9POT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN DIMETHICONE (13 CST)", "unii": "4QGR4P2YOI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps prevent sunburn lf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skinaging caused by the sun", "34068-7": "Directions apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water•resistant sunscreen if swimming or sweating 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 sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long•sleeved shirts, pants, hats, and sunglasses children under 6 months of age: ask a doctor", "34071-1": "Warnings For external use only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and aska doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "Keep out of reach of children.", "51727-6": "Inactive Ingredients Water, Butyloctyl Salicylate, C9- 12 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, lsodecyl Neopentanoate, Dicaprylyl Carbonate, Cetyl Alcohol, Coco-Caprylate/ Caprate, Propanediol, Ethylhexyl Olivate, Glyceryl Stearate, PEG-I00 Stearate, Cetearyl Olivate, Stearyl Phosphate, Triethoxycaprylylsilane, Phenoxyethanol, Oleth•3 Phosphate, Sorbitan Olivate, HDI/Trimethylol Hexyllactone Crosspolymer, Alumina, Xanthan Gum, Polymethylsilsesquioxane, Polyhydroxystearic Acid, Squalane, Gluconolactone, Sodium Phytate, lsopropyl Titanium Triisostearate, Sodium Benzoate, Hydrogen Dimethicone, Potassium Sorbate, Silica, Tocopheryl Acetate, Ascorbic Acid, Diamond Powder, Iron Oxides, Mica", "53413-1": "Question or comments? Call toll free 1-800-PTR-SKIN (787-7546)", "55105-1": "Active Ingredients.............................................................. Purpose Titanium Dioxide I.93%................................................... Sunscreen Zinc Oxide 19.24%..... ................................................... Sunscreen", "55106-9": "Titanium Dioxide I.93% Zinc Oxide 19.24%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.753353 · Updated: 2026-03-14T23:01:49.492831