HELLO, SUNSHINE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN- homosalate, oxybenzone, octisalate, avobenzone, and octocrylene liquid

hello, sunshine moisturizer Broad Spectrum SPF 30 sunscreen by

Drug Labeling and Warnings

hello, sunshine moisturizer Broad Spectrum SPF 30 sunscreen by is a Otc medication manufactured, distributed, or labeled by Tarte, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%

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.

Stop use and ask doctor if rash occurs.

Do not use on damaged or broken skin.

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

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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: Ask a doctor.
• Apply to all skin exposed to the sun.
• 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 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 sunlight.
• You may report a serious adverse reaction to: Awake Beauty c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.

Inactive Ingredients

Water, glyceryl stearate, glycerin, propanediol, cetearyl alcohol, squalene, stearic acid, C12-15 alkyl benzoate, butylene glycol, dimethicone, polyester-8, polysorbate 60, potassium cetyl phosphate, helianthus annuus (sunflower) seed oil, citrus aurantium dulcis (orange) oil, phenoxyethanol, sclerotium gum, phenylethyl resorcinol, tribehenin, dimethiconol, caprylyl glycol, chlorphenesin, allantoin, tocopheryl acetate, disodium EDTA, sodium hydroxide, ceramide NG, PEG-10 phytosterol, sodium PCA, glycine soja (soybean) oil, hydrogenated lecithin, oligopeptide-68, sodium oleate, linalool, citral, sodium carbonate, limonene, tocopherol, palmitoyl hexapeptide-12, mica, titanium dioxide, iron oxides. OX100AWFZ000022.

SPL UNCLASSIFIED SECTION

Dist. By Awake Beauty, Inc. New York, NY 10018.

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

Awake

Hello, Sunshine
moisturizer
Broad Spectrum SPF 30
sunscreen

net 50 mL / 1.70 Fl. Oz.

INGREDIENTS AND APPEARANCE

HELLO, SUNSHINE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN 
homosalate, oxybenzone, octisalate, avobenzone, and octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-242
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CERAMIDE NG (UNII: C04977SRJ5)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM OLEATE (UNII: 399SL044HN)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
SODIUM CARBONATE (UNII: 45P3261C7T)
ORANGE OIL (UNII: AKN3KSD11B)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
TOCOPHEROL (UNII: R0ZB2556P8)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
FARNESOL (UNII: EB41QIU6JL)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-242-01	1 in 1 CARTON	07/06/2017
1		50 mL in 1 JAR; 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	07/06/2017

Labeler - Tarte, Inc. (027905186)