OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREEN- zinc oxide lotion

OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREEN by

Drug Labeling and Warnings

OPEN NATURE CHILDREN 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 ingredients

Zinc Oxide 21.6%

Purpose

Sunscreen

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.

Stop use and ask a doctor if

• rash occurs

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, octyldodecyl citrate crosspolymer, phenyl trimethicone, cetyl  PEG/PPG-10/1 dimethicone, dimethicone, polyhydroxystearic acid, glycerin, ethyl methicone, cetyl dimethicone, silica, colloidal oatmeal, 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 CHILDREN'S SPF 50 SUNSCREEN LOTION

3.0 FL OZ. (89mL)

NDC: 21130-725-03

INGREDIENTS AND APPEARANCE

OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	216 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
OATMEAL (UNII: 8PI54V663Y)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-725-03	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(21130-725)