SAND AND SKY TINTED GLOW PRIMER SPF30- avobenzone, homosalate, octisalate, octocrylene lotion

SAND AND SKY TINTED GLOW PRIMER SPF30 by

Drug Labeling and Warnings

SAND AND SKY TINTED GLOW PRIMER SPF30 by is a Otc medication manufactured, distributed, or labeled by Supernova USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active
Ingredients                       Purpose

Avobenzone 3.0%           Sunscreen

Homosalate 8.0%            Sunscreen

Octisalate 4.0%               Sunscreen

Octocrylene 2.0%           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

Store below 30°C / 86°F and avoid direct sunlight.

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. When using this product keep out of eyes. Rinse with water to remove.

Directions

• Apply daily as the last step in your morning routine on your face, neck and decolletage.
• Apply liberally and evenly 20 minutes before sun exposure.
• Layer with additional sunscreen that is water-resistant especially when going outdoor and to the beach.
• Reapply every 2 hours.
• 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 10 a.m. - 2. p.m.
  • Wear a long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients Aqua / Water / Eau, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Isostearyl Neopentanoate, Glycerin, Cyclohexasiloxane, Ceteareth-20, Chondrus Crispus Extract, Cetearyl Alcohol, Prunus Armeniaca Kernel Oil, Panthenyl Triacetate, Hydrolyzed Hyaluronic Acid, Tocopherol, Glycine Soja Oil, Panthenol, Serine, Allantoin, Sodium Hyaluronate Crosspolymer, Sorbitol, Urea, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate / VP Copolymer, Xanthan Gum, PEG-40 Stearate, Triacontanyl PVP, Silica, Cetyl Dimethicone, Ethyl Linoleate, Caprylhydroxamic Acid, Pentylene Glycol, Oleyl Alcohol, Disodium EDTA, Lactic Acid, Fragrance / Parfum, Sodium Lactate, Sodium Chloride, Ethylhexylglycerin, CI 77491, CI 77492, Limonene, Linalool.

Other information

Protect the product from excessive heat and direct sun

STORAGE AND HANDLING

Questions? Contact (626) 616-5811

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

SAND & SKY

Tinted Glow
Primer
SPF30

Base De Teint Éclat
SPF30

Lightweight

UVA + UVB
Broad Spectrum
SPF30
Universal Tint

Net 60 mL / 2.03 fl. oz. US

INGREDIENTS AND APPEARANCE

SAND AND SKY TINTED GLOW PRIMER SPF30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82931-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
HYALURONIC ACID (UNII: S270N0TRQY)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
PANTHENOL (UNII: WV9CM0O67Z)
SERINE (UNII: 452VLY9402)
ALLANTOIN (UNII: 344S277G0Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SORBITOL (UNII: 506T60A25R)
UREA (UNII: 8W8T17847W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-40 STEARATE (UNII: ECU18C66Q7)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Product Characteristics
Color	PINK (Light pink lotion)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82931-001-60	1 in 1 CARTON	01/01/2023
1		60 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 final	part352	01/01/2023

Labeler - Supernova USA Inc. (116909952)