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

(re) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen Spf 35
SPL v5
SPL
SPL Set ID af4b0f17-43ec-a176-e053-2a95a90a7ac6
Route
TOPICAL
Published
Effective Date 2020-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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 evely 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

Medium

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 evely 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

Medium

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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