OPEN NATURE SPF 50 MINERAL SUNSCREEN- zinc oxide lotion

OPEN NATURE SPF 50 MINERAL SUNSCREEN by

Drug Labeling and Warnings

OPEN NATURE SPF 50 MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by SAFEWAY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 21.6%

Purpose

Sunscreen

INDICATIONS & USAGE

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

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.

ASK DOCTOR

Stop use and ask a doctor if

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: ask a doctor
• 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 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-sleeve shirts, pants, hats, and sunglasses

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octydodecyl citrate crosspolmyer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, glycerin, polyhydroxystearic acid, ethyl methicone, cetyl dimethicone, silica, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, bis-divinyl dimethicone/PEG-10 dimethicone crosspolymer, sodium chloride, phenoxyethanol, chlorphenesin

PRINCIPAL DISPLAY PANEL

OPEN NATURE SPF 50 MINERAL SUNSCREEN LOTION

3 FL OZ. (89mL)

NDC: 21130-723-03

INGREDIENTS AND APPEARANCE

OPEN NATURE SPF 50 MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-723
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	216 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-723-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	12/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/02/2019

Labeler - SAFEWAY, INC. (009137209)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		080086802	manufacture(21130-723)