OUNCE BY OUNCE BROAD SPECTRUM SUNSCREEN SPF 30- zinc oxide lotion

Ounce by Ounce Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Ounce by Ounce Broad Spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Zinc Oxide 15.7% 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 skin 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

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

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• wear 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 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

INACTIVE INGREDIENT

Inactive Ingredient Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Sodium Gluconate, Sodium Stearoyl Glutamate, Tetradecane, Tocopherol, Water, Xanthan Gum

OTHER SAFETY INFORMATION

Other Information Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Ounce by Ounce

Supergoop

SPF 30

Everyday Mineral Lotion

Broad Spectrum Sunscreen SPF 30

18 fl. oz. / 532 ml.

INGREDIENTS AND APPEARANCE

OUNCE BY OUNCE BROAD SPECTRUM SUNSCREEN SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
TETRADECANE (UNII: 03LY784Y58)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
DOCOSANOL (UNII: 9G1OE216XY)
COCONUT OIL (UNII: Q9L0O73W7L)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-158-01	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/26/2021

Labeler - Supergoop, LLC (117061743)

Registrant - Bell International Laboratories (967781555)