Play 100% Mineral Lotion Broad Spectrum Sunscreen Spf 50

Play 100% Mineral Lotion Broad Spectrum Sunscreen Spf 50
SPL v3
SPL
SPL Set ID 89088ac5-f1ee-1996-e053-2a95a90a8fdc
Route
TOPICAL
Published
Effective Date 2019-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2 g) Zinc Oxide (24 g)
Inactive Ingredients
Cetyl Esters Wax Coco-caprylate/caprate Perilla Frutescens Seed Oil Silicon Dioxide Hydrolyzed Jojoba Esters (acid Form) Haematococcus Pluvialis Helianthus Annuus Seed Wax Hydrogenated Rapeseed Oil Isopropyl Palmitate Polyhydroxystearic Acid (2300 Mw) Pomegranate Seed Oil Stearic Acid Water Sodium Chloride Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-05-16

Description

Active Ingredients Purpose Titanium Dioxide 2% Sunscreen Zinc Oxide 24% Sunscreen


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.

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

Apply liberally 15 minutes before sun exposure

Reapply:

  • after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours

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 value 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Description

Active Ingredients Purpose Titanium Dioxide 2% Sunscreen Zinc Oxide 24% Sunscreen

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients

C9-12 Alkane, Caprylic/Capric Triglyceride, Cetyl Esters, Coco-Caprylate/Caprate, Haematococcus Pluvalis Extract, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Hydrogenated Rapeseed Oil, Hydrolyzed Jojoba Esters, Isopropyl Palmitate, Jojoba Esters, Perilla Ocymoides (Perilla) Seed Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Seed Oil, Sea Water, Silica, Stearic Acid, Water

Section 51945-4

Play 100% Mineral Lotion

with green Algae

Broad Spectrum Sunscreen SPF 50

Water Resistant (80 Minutes)

Section 55105-1

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 55106-9

Active Ingredients Purpose

Titanium Dioxide 2% Sunscreen

Zinc Oxide 24% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions

Apply liberally 15 minutes before sun exposure

Reapply:

  • after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours

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 value 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: 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.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

C9-12 Alkane, Caprylic/Capric Triglyceride, Cetyl Esters, Coco-Caprylate/Caprate, Haematococcus Pluvalis Extract, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Hydrogenated Rapeseed Oil, Hydrolyzed Jojoba Esters, Isopropyl Palmitate, Jojoba Esters, Perilla Ocymoides (Perilla) Seed Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Seed Oil, Sea Water, Silica, Stearic Acid, Water

Section 51945-4 (51945-4)

Play 100% Mineral Lotion

with green Algae

Broad Spectrum Sunscreen SPF 50

Water Resistant (80 Minutes)

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active Ingredients Purpose

Titanium Dioxide 2% Sunscreen

Zinc Oxide 24% Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)