Sunny Skies Facial Moisturizer, SPF 30 - 85623-101

Sunny Skies Facial Moisturizer by

Drug Labeling and Warnings

Sunny Skies Facial Moisturizer by is a Otc medication manufactured, distributed, or labeled by Give Back Beauty, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNNY SKIES FACIAL MOISTURIZER- zinc oxide lotion 
Give Back Beauty, LLC

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Sunny Skies Facial Moisturizer, SPF 30 - 85623-101

Active Ingredient

Zinc Oxide 18%

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

Inactive Ingredients

Aqua (Water, Eau), Polyhydroxystearic Acid, C13-15 Alkane, Pentylene Glycol, C15-19 Alkane, Propanediol, Physalis Alkekengi Calyx Extract, Tocopherol, Caprylic/Capric Triglyceride, Gluconolactone, Bis-Diglyceryl Polyacyladipate-2, Polyacrylate Crosspolymer-6, Cetearyl Alcohol, Bisabolol, Inosito, Polyglycery-3. Polyricinoleate, Lecithin, Isostearic Acid, Coco-Glucoside, Arachidyl Alcohol, Polyglycer -3 Lactate/Laurate, Polyglycerin-3, Arachidyl Glucoside, Sodium Dilauramidoglutamide Lysine, Sclerotium Gum, Behenyl Alcohol, Xanthan Gum, Glucose, Beta-Carotene, Sodium Phytate, t-Butyl Alcohol, Calcium Gluconate, Sodium Benzoate, Sodium Citrate, Citric Acid.

Other Information

Protect this product from excessive heat and direct sun.

SUNNY SKIES FACIAL MOISTURIZER 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85623-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-5 POLYRICINOLEATE (UNII: FT3MR7CR64)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID (UNII: 2968PHW8QP)
GLUCOSE (UNII: 5SL0G7R0OK)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
C15-19 ALKANE (UNII: CI87N1IM01)
PROPANEDIOL (UNII: 5965N8W85T)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BISABOLOL (UNII: 24WE03BX2T)
C13-15 ALKANE (UNII: 114P5I43UJ)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
PHYSALIS ALKEKENGI CALYX (UNII: AL7F9NO9HR)
SODIUM PHYTATE (UNII: 88496G1ERL)
BETA-CAROTENE (UNII: 01YAE03M7J)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
INOSITOL (UNII: 4L6452S749)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
COCO-GLUCOSIDE (UNII: ICS790225B)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85623-101-50	50 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2022	07/31/2025

Labeler - Give Back Beauty, LLC (117297657)

Revised: 6/2025

Document Id: 36c66ef8-af4e-c849-e063-6294a90a0e44

34390-5

Set id: 36b105ef-82a9-7f95-e063-6394a90a8c1b

Version: 2

Effective Time: 20250604