SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM SPF 30 MINERAL MILK SUNSCREEN- zinc oxide cream

Summer Fridays Shadedrops Broad Spectrum SPF 30 Mineral Milk Sunscreen by

Drug Labeling and Warnings

Summer Fridays Shadedrops Broad Spectrum SPF 30 Mineral Milk Sunscreen by is a Otc medication manufactured, distributed, or labeled by Summer Fridays LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 9.40%

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.

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

Shake well 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 of age: Ask a doctor 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






Sun Protection Measures.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Sorbitan Oleate Decylglucoside Crosspolymer, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glycerin, Caramel, Polyester-5, Squalane, Butyrospermum Parkii (Shea) Butter Extract, Bisabolol, Phospholipids, Tocopherol, Ethyl Ferulate, Urea, Ethylhexylglycerin, Gluconolactone, Triethoxycaprylylsilane, Dimethicone, Sodium Chloride, Benzyl Alcohol, Sodium Benzoate, Sorbic Acid, Chlorphenesin, Phenoxyethanol.

Package Labeling:81678-000-01

Package Labeling:81678-000-02

INGREDIENTS AND APPEARANCE

SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM SPF 30 MINERAL MILK SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81678-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	94 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
GLYCERIN (UNII: PDC6A3C0OX)
CARAMEL (UNII: T9D99G2B1R)
SQUALANE (UNII: GW89575KF9)
SHEA BUTTER (UNII: K49155WL9Y)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYL FERULATE (UNII: 5B8915UELW)
UREA (UNII: 8W8T17847W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81678-000-01	1 in 1 CARTON	05/01/2022
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 81678-000-02	1 in 1 CARTON	05/01/2022
2		5 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	05/01/2022

Labeler - Summer Fridays LLC (118620216)