TEATRICAL PRO-ACLARANT DAY- avobenzone, octinoxate, and octocrylene cream

Teatrical Pro-Aclarant Day by

Drug Labeling and Warnings

Teatrical Pro-Aclarant Day by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Octinoxate 7.0%	Sunscreen
Octocrylene 5.0%	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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use

• apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating.

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 skin protection measures including:

• limit time in the sun, especially from 10am to 2pm
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Other information

• protect from excessive heat and direct sun.
• may stain some fabrics.
• keep this carton for future reference.

Inactive ingredients

WATER, CETYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLENE GLYCOL, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, ISOPROPYL PALMITATE, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, BUTYROSPERMUM PARKII BUTTER, PANTHENOL, STEARETH-20, SODIUM HYALURONATE, NIACINAMIDE, TETRAHEXYLDECYL ASCORBATE, CAMELLIA SINENSIS LEAF EXTRACT, PHENOXYETHANOL, BENZOIC ACID, ETHYLHEXYLGLYCERIN.

Questions or comments?

Call toll free 1-877-994-3666

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc., Houston,
TX 77027

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

WITH SUNSCREEN

teatrical®

PRO-ACLARANT
SKIN BRIGHTENING

DAY
CREAM

15
SPF BROAD SPECTRUM

VITAMIN B3 &
WHITE TEA EXTRACT

Helps unify skin tone
Prevents sun damage on skin

NET WT 1.7 OZ (48 g)

INGREDIENTS AND APPEARANCE

TEATRICAL PRO-ACLARANT DAY 
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	70 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Cetyl alcohol (UNII: 936JST6JCN)
PEG-100 stearate (UNII: YD01N1999R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Butylene Glycol (UNII: 3XUS85K0RA)
Dimethicone (UNII: 92RU3N3Y1O)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-071-01	1 in 1 CARTON	04/22/2020
1		48 g 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 not final	part352	04/22/2020

Labeler - Genomma Lab USA (832323534)