SHEER PROTECTION SPF 30- zinc oxide cream

Sheer Protection SPF 30 by

Drug Labeling and Warnings

Sheer Protection SPF 30 by is a Otc medication manufactured, distributed, or labeled by Skin Script, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient(s): Zinc Oxide (13.5%)

PURPOSE

Purpose: Sunscreen

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control center right away.

INDICATIONS & USAGE

Uses:

• Helps prevent sunburn
• If used as directed with other 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 the product is swallowed, get medical help or contact a Posion Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

• Apply liberally 15 min 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeve shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

OTHER SAFETY INFORMATION

Other Information:

• Protect the product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHEER PROTECTION SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83657-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0135 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
PEG-60 GLYCERYL STEARATE (UNII: 85O35YN6YY)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WITCH HAZEL (UNII: 101I4J0U34)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
ALCOHOL (UNII: 3K9958V90M)
DOCOSANOL (UNII: 9G1OE216XY)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM LACTATE (UNII: TU7HW0W0QT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LEVOMENOL (UNII: 24WE03BX2T)
SANDALWOOD (UNII: 3641YW25N2)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BARLEY (UNII: 5PWM7YLI7R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
MALIC ACID, L- (UNII: J3TZF807X5)
MACADAMIA OIL (UNII: 515610SU8C)
FYTIC ACID (UNII: 7IGF0S7R8I)
ERGOTHIONEINE (UNII: BDZ3DQM98W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83657-610-03	60 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2023
2	NDC: 83657-610-08	7.5 g in 1 JAR; Type 0: Not a Combination Product	09/01/2023
3	NDC: 83657-610-63	7 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2023

Labeler - Skin Script, LLC (050951910)