100% Mineral Lotion Broad Spectrum Sunscreen Spf 50 With Green Algae

100% Mineral Lotion Broad Spectrum Sunscreen Spf 50 With Green Algae
SPL v4
SPL
SPL Set ID d6fcc065-cbcd-0b81-e053-2a95a90ab1f9
Route
TOPICAL
Published
Effective Date 2022-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.3 g) Zinc Oxide (17.9 g)
Inactive Ingredients
Arachidyl Alcohol Docosanol Butyloctyl Salicylate Sodium Gluconate Coco Glucoside Ethyl Ferulate Haematococcus Pluvialis Methyl Dihydroabietate Microcrystalline Cellulose Neopentyl Glycol Diheptanoate Polyester-7 Polyhydroxystearic Acid (2300 Mw) Sodium Stearoyl Glutamate Propanediol Sodium Chloride Arachidyl Glucoside Citric Acid Monohydrate Water Tocopherol Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Diheptyl Succinate Cetyl Alcohol Glycerin Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Medium-chain Triglycerides Astrocaryum Vulgare Kernel Oil Caprylhydroxamic Acid Levomenol Erythritol Lauryl Laurate Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-04

Description

Active Ingredients Purpose TItanium Dioxide 2.3% Sunscreen Zinc Oxide 17.9% 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.
  • If product is swallowed, get medical help or contact a Poison Control right away.
Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

  • apply generously and evenly 15 minutes before sun exposure

reapply

  • after80 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 of 15 or higher and other sub and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor
Description

Active Ingredients Purpose TItanium Dioxide 2.3% Sunscreen Zinc Oxide 17.9% Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Vulgare Kernel Oil, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, C13-14 Alkane, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucosde, Diheptyl Succinate, Erythritol, Ethyl Ferulate, Glycerin, Haematococcus Pluvialis Extract, Jojoba Esters, Lauryl Laurate, Methyl dihydroabietate, Microcrystalline Cellulose, Neopentyl Glycol Diheptanoate, Polyester-7, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sea Water, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water

Section 51945-4

Supergoop!

PLAY

SPF 50

100% Mineral Lotion

With Green Algae

Broad Spectrum Sunscreen SPF 50 PA++++

Water resistant (80 minutes)

3.4 fl. oz. / 100 ml.

Section 55105-1

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skincancer and early skin aging caused by the sun

Section 55106-9

Active Ingredients Purpose

TItanium Dioxide 2.3% Sunscreen

Zinc Oxide 17.9% 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 generously and evenly 15 minutes before sun exposure

reapply

  • after80 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 of 15 or higher and other sub and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.- 2 p.m.
  • Wear long-sleeved 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.
  • If product is swallowed, get medical help or contact a Poison Control right away.
Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Vulgare Kernel Oil, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, C13-14 Alkane, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucosde, Diheptyl Succinate, Erythritol, Ethyl Ferulate, Glycerin, Haematococcus Pluvialis Extract, Jojoba Esters, Lauryl Laurate, Methyl dihydroabietate, Microcrystalline Cellulose, Neopentyl Glycol Diheptanoate, Polyester-7, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sea Water, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water

Section 51945-4 (51945-4)

Supergoop!

PLAY

SPF 50

100% Mineral Lotion

With Green Algae

Broad Spectrum Sunscreen SPF 50 PA++++

Water resistant (80 minutes)

3.4 fl. oz. / 100 ml.

Section 55105-1 (55105-1)

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skincancer and early skin aging caused by the sun

Section 55106-9 (55106-9)

Active Ingredients Purpose

TItanium Dioxide 2.3% Sunscreen

Zinc Oxide 17.9% Sunscreen


Advanced Ingredient Data


Raw Label Data

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