ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40- octinoxate, octisalate, octocrylene, titanium dioxide, and zinc oxide liquid

ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 by

Drug Labeling and Warnings

ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
octinoxate 7.5%	Sunscreen
octisalate 2.0%	Sunscreen
octocrylene 2.0%	Sunscreen
titanium dioxide 3.0%	Sunscreen
zinc oxide 3.0%	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 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

For sunscreen use:

• apply generously and evenly 15 minutes before sun exposure
• reapply at least every two 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 10am – 2pm
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water\aqualeau butylene glycol cetyl alcohol neopentyl glycol diheptanoate c12-15 alkyl benzoate dimethicone laureth-4 peg-100 stearate synthetic wax hydrogenated lecithin panax ginseng root extract citrus aurantium amara (bitter orange) flower wax castanea sativa (chestnut) seed extract psidium guajava (guava) fruit extract citrus aurantium amara (bitter orange) flower water laminaria saccharina extract triticum vulgare (wheat) germ extract pantethine hordeum distichon (barley) extract\extrait d'orge a deux rangs folic acid tourmaline cordyceps sinensis extract ethylhexylglycerin caffeine sodium hyaluronate yeast extract\faex\extrait de levure triethyl citrate isopropyl myristate sorbitan isostearate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer trehalose vp/hexadecene copolymer squalane caprylyl glycol tocopheryl acetate isostearic acid acrylates/ammonium methacrylate copolymer dimethicone silylate polyhydroxystearic acid magnesium ascorbyl phosphate nylon-12 xanthan gum hexylene glycol polysorbate 60 silica citrus grandis (grapefruit) peel oil*, citrus limon (lemon) peel oil*, citrus aurantium dulcis (orange) peel oil*, mentha viridis (spearmint) leaf oil* linalool limonene bht phenoxyethanol titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499) <iln52035> *essential oil

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

ORIGINS

GINZING™

SPF 40

Energy-Boosting

Tinted Moisturizer

Broad Spectrum

SPF 40

Sheer Tint Release

1.7 fl.oz./oz. liq./50 ml e

INGREDIENTS AND APPEARANCE

ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 
octinoxate, octisalate, octocrylene, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BARLEY (UNII: 5PWM7YLI7R)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAURETH-4 (UNII: 6HQ855798J)
PEG-100 STEARATE (UNII: YD01N1999R)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
SPEARMINT OIL (UNII: C3M81465G5)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
CITRUS AURANTIUM FLOWER WAX (UNII: 02171IZX8X)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
GUAVA (UNII: 74O70D6VG0)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
WHEAT GERM (UNII: YR3G369F5A)
PANTETHINE (UNII: 7K81IL792L)
ALV-001 (UNII: 8ZDZ2HTA6B)
FOLIC ACID (UNII: 935E97BOY8)
SCHORL TOURMALINE (UNII: 173O8XLY6T)
OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAFFEINE (UNII: 3G6A5W338E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
TREHALOSE (UNII: B8WCK70T7I)
AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)
SQUALANE (UNII: GW89575KF9)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
NYLON-12 (UNII: 446U8J075B)
XANTHAN GUM (UNII: TTV12P4NEE)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-016-01	1 in 1 CARTON	04/26/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59427-016-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	11/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	04/26/2021

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(59427-016) , pack(59427-016) , label(59427-016)