100% MINERAL BROAD SPECTRUM SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

100% Mineral Broad Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

100% Mineral Broad Spectrum Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Supergoop LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

TItanium Dioxide 2.3% Sunscreen

Zinc Oxide 17.9% Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & 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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

100% MINERAL BROAD SPECTRUM SUNSCREEN SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM GLUCONATE (UNII: R6Q3791S76)
COCO GLUCOSIDE (UNII: ICS790225B)
ETHYL FERULATE (UNII: 5B8915UELW)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-7 (UNII: 0841698D2F)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
LEVOMENOL (UNII: 24WE03BX2T)
ERYTHRITOL (UNII: RA96B954X6)
LAURYL LAURATE (UNII: GPW77G0937)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-362-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2022
2	NDC: 75936-362-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/04/2022

Labeler - Supergoop LLC (117061743)