DAILY MOISTURIZING ANTIOXIDANT SPF 50- avobenzone, homosalate, octinoxate, octisalate cream

Daily Moisturizing Antioxidant SPF 50 by

Drug Labeling and Warnings

Daily Moisturizing Antioxidant SPF 50 by is a Otc medication manufactured, distributed, or labeled by Goodier Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Revision Multi-Protection Broad-Spectrum SPF 50

Multi-Protection
Broad-Spectrum
SPF 50

daily oil-free anti-aging
moisturizer with sunscreen

NET WT 1.7 OZ | 48 g

Active ingredient          Purpose

Avobenzone 3% ........... Sunscreen
Homosalate 3% ............ Sunscreen
Octinoxate 7.5% .......... Sunscreen
Octisalate 4% ............... 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions
apply liberally 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 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
children under 6 months: Ask a doctor

Inactive ingredientsWater (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Cetearyl Alcohol, Polyglyceryl-3-Methylglucose Distearate, Boron Nitride,
Hydrogenated Starch Hydrolysate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Tetrahexyldecyl Ascorbate, Yeast Extract
(Faex), Camellia Sinensis (Green Tea) Leaf Extract, Epigallocatechin Gallate, Betula Alba (White Birch) Bark Extract, Biosaccharide Gum-1,
Ubiquinone, Cetyl Dimethicone, Palmitoyl Tripeptide-5, Squalane, Sodium Hyaluronate, Palmitoyl Dipeptide-5 Diaminobutyroyl
Hydroxythreonine, Punica Granatum (Pomegranate) Extract, Plankton Extract, Steareth-20, Tocopheryl Acetate, Allantoin, Lecithin,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Glyceryl Caprylate, Carbomer, Leuconostoc/Radish Root Ferment Filtrate,
Tocopherol, Steareth-10, Jojoba Bean Meal, Disodium EDTA, Magnesium Chloride, Potassium Sorbate, Fragrance (Parfum).

Other information
protect this product from excessive heat and direct sun

Dist. by Revision, LP
Irving, TX 75063 Made in U.S.A.

Revercel AM Moisturizing Sunscreen Broad Spectrum SPF 50

am
moisturizing
sunscreen

broad spectrum
spf 50

net wt. 1.7oz. | 48g

Active ingredient          Purpose
Avobenzone 3% ........... Sunscreen
Homosalate 3% ............ Sunscreen
Octinoxate 7.5% .......... Sunscreen
Octisalate 4% ............... 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions
apply liberally 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 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
children under 6 months: Ask a doctor

Inactive ingredients
Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Cetearyl Alcohol, Polyglyceryl-3-Methylglucose Distearate,
Boron Nitride, Sorbitol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Tetrahexyldecyl Ascorbate, Palmitoyl
Tripeptide-5, Glyceryl Caprylate, Leuconostoc/Radish Root Ferment Filtrate, Cetyl Dimethicone, Tocopherol, Squalane,
Steareth-20, Jojoba Bean Meal, Allantoin, Plankton Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Lecithin,
Sodium Hyaluronate, Betula Alba (White Birch) Bark Extract, Punica Granatum (Pomegranate) Extract, Yeast Extract (Faex),
Biosaccharide Gum-1, Tocopheryl Acetate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Epigallocatechin
Gallate, Camellia Sinensis (Green Tea) Leaf Extract, Ubiquinone, Magnesium Chloride, Carbomer, Disodium EDTA, Steareth-10,
Potassium Sorbate, Fragrance (Parfum)

Other information
protect this product from excessive heat and direct sun

Made in the USA
Distributed by Revercel LLC
Campbel, CA 95008

PRINCIPAL DISPLAY PANEL

1.7oz MPC

8oz MPC

3g MPC

1.7oz AM

INGREDIENTS AND APPEARANCE

DAILY MOISTURIZING ANTIOXIDANT SPF 50 
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10477-7720
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BORON NITRIDE (UNII: 2U4T60A6YD)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
YEAST (UNII: 3NY3SM6B8U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
UBIDECARENONE (UNII: EJ27X76M46)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
SQUALANE (UNII: GW89575KF9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)
POMEGRANATE (UNII: 56687D1Z4D)
STEARETH-20 (UNII: L0Q8IK9E08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARETH-10 (UNII: FD0913P475)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-7720-1	1 in 1 CARTON	06/26/2013
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10477-7720-2	227 g in 1 TUBE; Type 0: Not a Combination Product	06/26/2013
3	NDC: 10477-7720-3	3 g in 1 TUBE; Type 0: Not a Combination Product	06/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/26/2013

Labeler - Goodier Cosmetics LLC (007317209)

Registrant - Goodier Cosmetics LLC (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LLC		007317209	manufacture(10477-7720)