Beauty Counter Countersun Mineral Sunscreen Lotion SPF30

BeautyCounter Countersun Mineral Sunscreen by

Drug Labeling and Warnings

BeautyCounter Countersun Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Beauty Counter, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BEAUTYCOUNTER COUNTERSUN MINERAL SUNSCREEN SPF30- zinc oxide lotion 
Beauty Counter, LLC

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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Beauty Counter Countersun Mineral Sunscreen Lotion SPF30

Zinc Oxide 15.4%

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 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.
• Reapply:
• after 40 minutes of swimming or sweating.
• immediately after towel drying.
• 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 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 the product in this container from excessive heat and direct sun.

Inactive Ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Beeswax, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cetearyl Nonanoate, Citric Acid, Coco-Caprylate, Decylene Glycol, Ethylhexyl Palmitate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Isopropyl Myristate, Isopropyl Palmitate, Isostearic Acid, Lauroyl Lysine, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyhydroxystearic Acid, Potassium Sorbate, Silica, Sodium Benzoate, Sodium Chloride, Stearic Acid, Tocopherol, Water, Zinc Stearate

BEAUTYCOUNTER COUNTERSUN MINERAL SUNSCREEN  SPF30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69026-499
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
LAUROYL LYSINE (UNII: 113171Q70B)
ZINC STEARATE (UNII: H92E6QA4FV)
TOCOPHEROL (UNII: R0ZB2556P8)
COCO-CAPRYLATE (UNII: 4828G836N6)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEARIC ACID (UNII: 4ELV7Z65AP)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
DECYLENE GLYCOL (UNII: S57M60MI88)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69026-499-04	1 in 1 CARTON	10/13/2022
1	NDC: 69026-499-03	100 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69026-499-06	1 in 1 CARTON	10/13/2022
2	NDC: 69026-499-05	198 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 not final	part352	10/13/2022

Labeler - Beauty Counter, LLC (070346240)

Revised: 10/2022

Document Id: eaf0bddf-6cdf-9c4c-e053-2a95a90ab299

34390-5

Set id: eaf0bddf-6cde-9c4c-e053-2a95a90ab299

Version: 1

Effective Time: 20221013