SURYA NATURAL MINERAL SUNSCREEN- zinc oxide cream 
Hale Cosmeceuticals

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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Surya Natural Mineral Sunscreen

Drug Facts

Active Ingredients:

Zinc Oxide 20%

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

Stop use and ask a doctor 

• if rash occurs

When using this product

• keep out of eyes. • Rinse with water to remove.

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 • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: 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 value 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

• protect this product from excessive heat and direct sun • may stain some fabrics.

Inactive Ingredients

• Caprylic/Capric Triglyceride, Persea Gratissima (Avocado) Oil, Beeswax, Cocos Nucifera (Coconut) Oil, Soybean Glycerides, Shea Butter Unsaponificables, Tocopheryl Acetate, Bisabolol, Butyrospermum Parkii (Shea) Butter, Sesamum Indicum (Sesame) Seed Oil, Emblica Officinalis Fruit Extract, Curcumin, Copernicia Cerifera (Carnauba) Wax, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrobisdemethoxydiferuloylmethane, Potassium Cocoate, Tetrahexyldecyl Ascorbate, Fragrance.

Questions or comments?

Visit www.hncproducts.com or call 309-319-2151.

Package Labeling:

Label2

SURYA NATURAL MINERAL SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71987-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCONUT OIL (UNII: Q9L0O73W7L)  
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LEVOMENOL (UNII: 24WE03BX2T)  
SHEA BUTTER (UNII: K49155WL9Y)  
SESAME OIL (UNII: QX10HYY4QV)  
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
CURCUMIN (UNII: IT942ZTH98)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
TETRAHYDRODEMETHOXYDIFERULOYLMETHANE (UNII: 44D8X9U00T)  
TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I)  
POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71987-009-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/202212/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/202212/31/2024
Labeler - Hale Cosmeceuticals (168405822)

Revised: 11/2022
Document Id: ed231fc9-06df-261b-e053-2a95a90a063c
Set id: 03db613d-09de-4c06-a52c-feecdfd500c6
Version: 2
Effective Time: 20221110
 
Hale Cosmeceuticals