(GLOW)SETTING 100% MINERAL POWDER SPF 35- zinc oxide powder

(Glow)Setting 100% Mineral Powder SPF 35 by

Drug Labeling and Warnings

(Glow)Setting 100% Mineral Powder SPF 35 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

(Glow)setting 100% Mineral Powder

Zinc Oxide 2.4% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early sking aging caused by the sun

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION

Directions

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

Warnings

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs
• When using this product keep out of eyes
• Rinse with water to remove

INACTIVE INGREDIENT

Inactive Ingredients

Synthetic Fluorphlogopite, Silica, Trimethylsiloxysilicate, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Calcium Sodium Borosilicate, Boron Nitride, Polyglyceryl-10 Pentaisostearate, Lauroyl Lysine, Triethoxycaprylylsilane, Ethylhexylglycerin, Water (Aqua), Nylon-12, Propanediol, Sodium Dehydroacetate, Oryza Sativa (Rice) Bran Extract, Aletris Farinosa Root Extract, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Titanium Dioxide (Cl 77891), Iron Oxides (Cl 77492, 77491, 77499)

PRINCIPAL DISPLAY PANEL

(Glow)Setting 100% Mineral Powder

SPF 35

Broad Spectrum Sunscreen

0.13 oz. / 3.7 g.

INGREDIENTS AND APPEARANCE

(GLOW)SETTING 100% MINERAL POWDER SPF 35 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
BORON NITRIDE (UNII: 2U4T60A6YD)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPANEDIOL (UNII: 5965N8W85T)
ALETRIS FARINOSA ROOT (UNII: O021JGR97X)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRICLATE CALCIUM SODIUM (UNII: U7G9U9300W)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-603-02	1 in 1 BOX	10/18/2022
1	NDC: 75936-603-01	3.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	10/18/2022

Labeler - Supergoop, LLC (117061743)