SUNSCREEN SPF 30- zinc oxide cream 
Hamilton Therapeutics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Sunscreen SPF 30

Active ingredient Purpose
Zinc Oxide 15% .......................................................... Sunscreen

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. If swallowed, get medical help or contact a Poison Control Center right away.

• Stop use and ask a doctor if rash occurs.

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.

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 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.

SPF 30 Sunscreen

3.3FL OZ / 98mL

tube

SUNSCREEN SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72381-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LEVOMENOL (UNII: 24WE03BX2T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CHAMOMILE (UNII: FGL3685T2X)  
THYME (UNII: CW657OBU4N)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72381-102-0198 mL in 1 TUBE; Type 0: Not a Combination Product06/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/15/2018
Labeler - Hamilton Therapeutics (099419360)

Revised: 11/2022
Document Id: eeb62983-07d2-a44c-e053-2995a90a710d
Set id: 6e65bbab-954a-30ee-e053-2a91aa0a18ac
Version: 3
Effective Time: 20221130
 
Hamilton Therapeutics