JLO BEAUTY THAT BIG SCREEN BROAD SPECTRUM SPF 30 MOISTURIZER- homosalate, octisalate, and zinc oxide cream

JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer by

Drug Labeling and Warnings

JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer by is a Otc medication manufactured, distributed, or labeled by Ascendant Beauty LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Fact Label

Active ingredient

Homosalate - 15.0%
Octisalate – 5.0%
Zinc – 3.0%

Purpose

Sunscreen

Use

Helps prevent sunburn.

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

Apply a generous amount. Use daily in the morning. At least 15 minutes before sun exposure

• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Children under 6 months of age: ask a doctor
• Sun protection measures, Spending time in the sun increases your risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit in the sun, especially from 10 a.am. to 2 p.m.
• Wear long0sleeved shirts, pants, hats and sunglasses.

Other information

Protect this product from excessive heat and direct sun.

Active Ingredients

Homosalate – 15.0%, Octisalate - 5.0%, Zinc Oxide - 3.0%

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Hydrolyzed Vegetable Protein, Nelumbo Nucifera Flower Extract, Withania Somnifera Root Extract, Himanthalia Elongata Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Gigartina Stellata Extract, Hydrogenated Lecithin, Chondrus Crispus Extract, Camellia Sinensis Leaf Extract, Aspalathus Linearis Extract, Boswellia Serrata Extract, Honey Extract, Tocopheryl Acetate, Tocopherol, Ethyl Ferulate Trehalose, Disodium EDTA, Cetyl Palmitate, Bisabolol, Triethoxycaprylylsilane, Sorbitan Stearate, Polysorbate 80, Butylene Glycol, Sodium Hyaluronate, Isopentyldiol, Palmitoyl Tetrapeptide-10, Farnesol, Tetrapeptide-14, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Xanthan Gum, Citric Acid, Phenoxyethanol, Sodium Benzoate.

Questions or comments?

Visit JLoBeauty.com or toll-free 1-800-557-8164

SPL UNCLASSIFIED SECTION

Dist.by/par. Ascendant Beauty, LLC., El Segundo, CA 90245.

PRINCIPAL DISPLAY PANEL - 50 mL Jar Box

JLO BEAUTY™

THAT BIG SCREEN
IN A BROAD SPECTRUM SPF 30 MOISTURIZER
Hydrate. Protect. Soothe.

FIGHTS FREE RADICALS, UVA/UVB, INFRARED + BLUE LIGHT.

30+
SPF

1.7 fl. oz (50 mL)

INGREDIENTS AND APPEARANCE

JLO BEAUTY THAT BIG SCREEN BROAD SPECTRUM SPF 30 MOISTURIZER 
homosalate, octisalate, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79625-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	150 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Dimethicone (UNII: 92RU3N3Y1O)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MASTOCARPUS STELLATUS (UNII: 6T087FC66H)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
HONEY (UNII: Y9H1V576FH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Tocopherol (UNII: R0ZB2556P8)
ETHYL FERULATE (UNII: 5B8915UELW)
TREHALOSE (UNII: B8WCK70T7I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
LEVOMENOL (UNII: 24WE03BX2T)
Triethoxycaprylylsilane (UNII: LDC331P08E)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Butylene Glycol (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Isopentyldiol (UNII: 19NOL5474Q)
Palmitoyl Tetrapeptide-10 (UNII: 6Q6H1PKC05)
Farnesol (UNII: EB41QIU6JL)
Caprylyl Glycol (UNII: 00YIU5438U)
Hexylene Glycol (UNII: KEH0A3F75J)
Ethylhexylglycerin (UNII: 147D247K3P)
Xanthan Gum (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79625-001-07	15 mL in 1 JAR; Type 0: Not a Combination Product	04/01/2021
2	NDC: 79625-001-19	1 in 1 BOX	04/01/2021
2		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 drug	M020	04/01/2021

Labeler - Ascendant Beauty LLC (117586353)