SMART STUFF SPF30 4OZ- zinc oxide lotion 
Cosco International, Inc.

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.

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Active Ingredient

Active Ingredient                       Purpose
Zinc Oxide 20%........................Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and the early 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 skin rash occurs.

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

Directions

  • Apply liberally and evenly to skin 30 minutes prior to sun exposure.
  • Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.  Spending time in the sun increases your risk of skin and early skin aging.  To decrease risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higherand other sun protection measures including:
  • Limit time in sun, especially from 10 a.m. - 2 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Aqua (Water), Dicaprylyl Glycol, Caprylic/Capic Triglyceride, Diheptyl Succinate, Glycerin, Polyglyceryl-3 Diisostearate, Cetyl Alcohol, Jojoba Ester, Euphorbia Cerifera (Candelilla) Wax, Oryza Sativa (Rice) Bran Wax, Polyglycerin-3, Glyceryl Stearate, Emu Oil, Polyhydroxystearic Acid, Cetearyl Alcohol, Sodium Stearyl Lactylate, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Persea Gratissima (Avocado) Oil, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, CapryloylGlycerin/Sebacic Acid Copolymer, Sodium Phytate, Chamomilla Recutita (Matricaria) Flower Extract.

Other information

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

Questions or comments?

Call 1-855-776-2781

PDP

SMART STUFF SPF30 4OZ 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-2502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION23.7 g  in 118.294 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 49.4 g  in 118.294 g
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 11.8 g  in 118.294 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 9.5 g  in 118.294 g
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 9.0 g  in 118.294 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 8.1 g  in 118.294 g
OLIVE OIL (UNII: 6UYK2W1W1E) 6.0 g  in 118.294 g
AVOCADO OIL (UNII: 6VNO72PFC1) 6.0 g  in 118.294 g
MACADAMIA OIL (UNII: 515610SU8C) 6.0 g  in 118.294 g
XANTHAN GUM (UNII: TTV12P4NEE) 6.0 g  in 118.294 g
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) 5.723 g  in 118.294 g
GLYCERIN (UNII: PDC6A3C0OX) 3.5 g  in 118.294 g
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) 3.0 g  in 118.294 g
CETYL ALCOHOL (UNII: 936JST6JCN) 2.4 g  in 118.294 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1.4 g  in 118.294 g
EMU OIL (UNII: 344821WD61) 1.2 g  in 118.294 g
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH) 1.05 g  in 118.294 g
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.9 g  in 118.294 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.525 g  in 118.294 g
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) 0.525 g  in 118.294 g
POLIFEPROSAN 20 (UNII: S40C40DA21) 0.177 g  in 118.294 g
PHYTATE SODIUM (UNII: 88496G1ERL) 0.1 g  in 118.294 g
CHAMOMILE (UNII: FGL3685T2X) 0.1 g  in 118.294 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-2502-11 in 1 BOX06/04/201506/12/2018
1NDC:52261-2502-0118.294 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/04/201506/12/2018
Labeler - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-2502) , label(52261-2502) , pack(52261-2502)

Revised: 3/2018
Document Id: 6e147746-891d-43b0-83d5-3dd5628afe8b
Set id: b0c74b7d-5777-477e-8bcf-0ad36a8d5a09
Version: 4
Effective Time: 20180327
 
Cosco International, Inc.