(re) Setting 100% Mineral Powder Light Broad Spectrum Spf 35

(re) Setting 100% Mineral Powder Light Broad Spectrum Spf 35
SPL v5
SPL
SPL Set ID aed5a7ef-5cf2-6738-e053-2a95a90aa7f7
Route
TOPICAL
Published
Effective Date 2020-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.7 g)
Inactive Ingredients
Triethoxycaprylylsilane Ascorbyl Palmitate Silicon Dioxide Ethylhexylglycerin Poly(methyl Methacrylate; 450000 Mw) Trimethylsiloxysilicate (m/q 0.6-0.8) Lauroyl Lysine Ferric Oxide Yellow Calcium Aluminum Borosilicate Ferric Oxide Red Ferrosoferric Oxide Ceramide 3 Boron Nitride Sodium Dehydroacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-08

Description

Zinc Oxide 24.7% Purpose Sunscreen


Medication Information

Warnings and Precautions

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
  • apply generously and evenly 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 value of 15 or higher 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

Zinc Oxide 24.7% Purpose Sunscreen

Section 50565-1

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

Section 51727-6

Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylysilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron OXides (CI 77492, 77491, 77499)

Section 51945-4

Supergoop!

(RE) SETTING

100% MINERAL POWDER

SPF 35

Light

Broad Spectrum Sunscreen

SPF 35 PA+++

0.15 oz./4.25 g

Section 55105-1

Sunscreen

  • 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

Zinc Oxide 24.7% Purpose Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a Doctor if rash occurs.

Dosage and Administration (34068-7)
  • apply generously and evenly 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 value of 15 or higher 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)

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

Section 51727-6 (51727-6)

Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylysilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron OXides (CI 77492, 77491, 77499)

Section 51945-4 (51945-4)

Supergoop!

(RE) SETTING

100% MINERAL POWDER

SPF 35

Light

Broad Spectrum Sunscreen

SPF 35 PA+++

0.15 oz./4.25 g

Section 55105-1 (55105-1)

Sunscreen

  • 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)

Zinc Oxide 24.7% Purpose Sunscreen


Advanced Ingredient Data


Raw Label Data

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