HELLO SUN SILKY GLOW BROAD SPECTRUM SPF40- zinc oxide cream

Hello Sun Silky Glow Broad Spectrum SPF40 by

Drug Labeling and Warnings

Hello Sun Silky Glow Broad Spectrum SPF40 by is a Otc medication manufactured, distributed, or labeled by The Creme Shop, Cosmax USA, Corporation, Cosmax USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 12.24%

PURPOSE

Purpose

Sunscreen

USES

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

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 product is swallowed, get medical help or contact a Poison Control center right away.

DIRECTIONS

Directions

• Apply generously and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• 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 10am-2pm
• Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Isoamyl Laurate, Glycerin,Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Cetearyl Olivate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Olivate, Hydroxyacetophenone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Butylene Glycol, Cellulose Gum, Theobroma Cacao (Cocoa) Seed Extract.

OTHER INFORMATION

Other Information

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

QUESTIONS OR COMMENTS

Questions or Comments

Contact us at 1-866-993-4709 or lgbeauty.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HELLO SUN SILKY GLOW BROAD SPECTRUM SPF40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81123-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.24 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
CELLULOSE GUM (UNII: K679OBS311)
COCOA (UNII: D9108TZ9KG)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
GLYCERIN (UNII: PDC6A3C0OX)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
SORBITAN OLIVATE (UNII: MDL271E3GR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81123-330-01	1 in 1 CARTON	05/01/2025
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2025

Labeler - The Creme Shop (052907070)

Registrant - Cosmax USA, Corporation (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax USA		010990210	manufacture(81123-330)