Mineral Sunscreen Mist Spf 30

Mineral Sunscreen Mist Spf 30
SPL v3
SPL
SPL Set ID 4cf243b4-d794-401a-b209-18c7e550ef4f
Route
TOPICAL
Published
Effective Date 2017-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (12 g)
Inactive Ingredients
Filipendula Ulmaria Root Heptyl Undecylenate Hydrolyzed Jojoba Esters (acid Form) Melissa Officinalis Leaf Methyl Dihydroabietate Nasturtium Officinale Flowering Top Filipendula Ulmaria Flower Water Aloe Vera Leaf Bentonite Butyloctyl Salicylate Calendula Officinalis Flower Caprylhydroxamic Acid Caprylyl Glycol Glycerin Safflower Oil Cetostearyl Alcohol Chamomile Coco Glucoside Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-05-15

Description

​Active Ingredients                                    Purpose Zinc Oxide 12.0% ..................................... Sunscreen


Medication Information

Warnings and Precautions

Warnings

  • For external use only
  • Flammable: Contents under pressure. Do not punture or incinerate. Do not store at temperatures above 120 F. Do not use in the precesne of a flame or spark, or while smoking
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes
  • Rinse with water to remove
  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away

Indications and Usage

Stop use and ask a doctor is rash occurs

Dosage and Administration

​Directions

​SHAKE WELL to activate. If the mist is clear, keep shaking.

  • Apply liberally 15 minutes before sun exposure
  • Reapply:

- after 80 minutes of swimming or sweating

- immediately after towel drying

- at least every 2 hours whem exposed to sunlight

  • Children un 6 months: Ask 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 value of 15 or higher and other sun protection measures including:

  • Limit time in the sun epsecially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Description

​Active Ingredients                                    Purpose Zinc Oxide 12.0% ..................................... Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Aloe Barbadensis Leaf Juice, Bentonite, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco Glucoside, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Undecylenate, Jojoba Esters, Melissa Officinalis Leaf Extract, Methyl Dihydroabietate, Nasturtium Officinale Flower/Leaf Extract, Spiraea Ulmaria Flower Extract, Water

Section 51945-4

Supergoop!

Play

SPF 30

100% Mineral Body Mist

with Marigold Extract

Broad Spectrum Sunscreen SPF 30

Water Resistant (80 minutes)

6 fl. oz. / 177 mL.

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

Zinc Oxide 12.0% ..................................... Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor is rash occurs

Dosage and Administration (34068-7)

​Directions

​SHAKE WELL to activate. If the mist is clear, keep shaking.

  • Apply liberally 15 minutes before sun exposure
  • Reapply:

- after 80 minutes of swimming or sweating

- immediately after towel drying

- at least every 2 hours whem exposed to sunlight

  • Children un 6 months: Ask 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 value of 15 or higher and other sun protection measures including:

  • Limit time in the sun epsecially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Warnings and Precautions (34071-1)

Warnings

  • For external use only
  • Flammable: Contents under pressure. Do not punture or incinerate. Do not store at temperatures above 120 F. Do not use in the precesne of a flame or spark, or while smoking
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes
  • Rinse with water to remove
  • Keep out of reach of children
  • If 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)

Aloe Barbadensis Leaf Juice, Bentonite, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco Glucoside, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Undecylenate, Jojoba Esters, Melissa Officinalis Leaf Extract, Methyl Dihydroabietate, Nasturtium Officinale Flower/Leaf Extract, Spiraea Ulmaria Flower Extract, Water

Section 51945-4 (51945-4)

Supergoop!

Play

SPF 30

100% Mineral Body Mist

with Marigold Extract

Broad Spectrum Sunscreen SPF 30

Water Resistant (80 minutes)

6 fl. oz. / 177 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 skin cancer and early skin aging caused by the sun
Section 55106-9 (55106-9)

​Active Ingredients                                    Purpose

Zinc Oxide 12.0% ..................................... Sunscreen


Advanced Ingredient Data


Raw Label Data

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