SUNSCREEN SPF 30- zinc oxide cream

Sunscreen SPF 30 by

Drug Labeling and Warnings

Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Hamilton Therapeutics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose
Zinc Oxide 15% .......................................................... 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 aging caused by the sun.

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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Warnings

For external use only

When using this product keep out of eyes.

Rinse with water to remove.

Do not use on damaged or broken skin.

DOSAGE & ADMINISTRATION

Directions

For full protection, apply liberally 15 minutes before sun exposure.

Reapply: After 40 minutes of swimming or sweating immediately after towel drying

at least every 2 hours.

For children under 6 months: Ask a doctor. Sun Protection Measures: To decrease risk of exposure, regularly use a Broad Spectrum Sunscreen with an SPF of 15 or higher.

Limit time in the sun, especially from 10AM-2PM.

Wear long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT

Inactive ingredients Water, Caprylyl Caprylate/Caprate, Coconut Alkanes, Potassium Cetyl Phosphate, Cetearyl Alcohol, Glycerin, Bisabolol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Coco-Caprylate/Caprate, Glyceryl Stearate, Xanthan Gum, Polyhydroxystearic Acid, Glyceryl Distearate, Stearic Acid, Potassium Stearate, Octyldodecanol, Ethylhexyl Neopentanoate, Dimethicone, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylhydroxamic Acid.

PRINCIPAL DISPLAY PANEL

SPF 30 Sunscreen

3.3FL OZ / 98mL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72381-102
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)
ORANGE PEEL (UNII: TI9T76XD44)
LEMON PEEL (UNII: 72O054U628)
SAGE (UNII: 065C5D077J)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POTASSIUM STEARATE (UNII: 17V812XK50)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMOMILE (UNII: FGL3685T2X)
THYME (UNII: CW657OBU4N)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
COCONUT ALKANES (UNII: 1E5KJY107T)
GLYCERYL DISTEARATE (UNII: 73071MW2KM)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72381-102-01	98 mL in 1 TUBE; Type 0: Not a Combination Product	06/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/15/2018

Labeler - Hamilton Therapeutics (099419360)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC.		021072509	manufacture(72381-102)