Alex MD PhD Antidotal Skincare Daily Defense Tinted Mineral Anti-Aging Sunscreen by AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care / AMCOL Health & Beauty Solutions, Inc. DBA Drug Facts

Drug Details [pdf]

ALEX MD PHD ANTIDOTAL SKINCARE DAILY DEFENSE TINTED MINERAL ANTI-AGING SUNSCREEN- zinc oxide, titanium dioxide lotion
AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Titanium Dioxide, 6.8%

Zinc Oxide, 20.2%

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

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 liberally 15 minutes before sun exposure.

Reapply:

After 80 minutes of swimming or sweating.
Immediately after towel drying.
At least every 2 hours.

Children under 6 months:

Ask a doctor.

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 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.

Inactive Ingredients

Cyclopentasiloxane, Water/Aqua/Eau, Coco-Caprylate/Caprate, Isononyl Isononanoate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Undaria Pinnatifida Extract, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Astrocaryum Tucuma Seed Butter, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Tetrahexyldecyl Ascorbate, Dunaliella Salina Extract, Bisabolol, Ubiquinone, Ergothioneine, Tremella Fuciformis Sporocarp Extract, Tocopheryl Acetate, Betaine, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyglyceryl-3 Diisostearate, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate, C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (CI 77491, 77499, 77492)

Other information

Protect this product from excessive heat and direct sun

Principal Display Panel - 65 g Carton Label

ALEX MD PhD ANTIDOTAL SKINCARE

DAILY DEFENSE

TINTED MINERAL ANTI-AGING SUNSCREEN

BROAD SPECTRUM SPF 50+ WATER RESISTANT (80 MINUTES)

net wt 2.3 oz – 65 g

Principal Display Panel - 65 g Carton Label

ALEX MD PHD ANTIDOTAL SKINCARE DAILY DEFENSE TINTED MINERAL ANTI-AGING SUNSCREEN
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-072
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
zinc oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	zinc oxide	13.13 g in 1 g
titanium dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	titanium dioxide	4.42 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
cyclomethicone 5 (UNII: 0THT5PCI0R)
water (UNII: 059QF0KO0R)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
isononyl isononanoate (UNII: S4V5BS6GCX)
polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 MPA.S) (UNII: RLA2U05Z4Q)
glycerin (UNII: PDC6A3C0OX)
disteardimonium hectorite (UNII: X687XDK09L)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
undaria pinnatifida (UNII: ICV1OK7M1S)
astrocaryum aculeatum seed oil (UNII: JUP28JPX3K)
butyrospermum parkii (shea) butter unsaponifiables (UNII: 0C9AC7D6XU)
theobroma grandiflorum seed butter (UNII: I711F13FXM)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
dunaliella salina (UNII: F4O1DKI9A6)
.alpha.-bisabolol, (+/-)- (UNII: 36HQN158VC)
ubidecarenone (UNII: EJ27X76M46)
ergothioneine (UNII: BDZ3DQM98W)
tremella fuciformis fruiting body (UNII: GG8N28393G)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
betaine (UNII: 3SCV180C9W)
lavender oil (UNII: ZBP1YXW0H8)
orange oil (UNII: AKN3KSD11B)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
caprylyl glycol (UNII: 00YIU5438U)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylhydroxamic acid (UNII: UPY805K99W)
squalane (UNII: GW89575KF9)
polyglyceryl-3 pentaricinoleate (UNII: 7Q0OK5DOT4)
alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
sodium chloride (UNII: 451W47IQ8X)
phenoxyethanol (UNII: HIE492ZZ3T)
ethylhexylglycerin (UNII: 147D247K3P)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68634-072-01	1 in 1 CARTON	01/07/2021	01/07/2021
1		65 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/07/2021

Labeler - AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care (872684803)

Name	Address	ID/FEI	Business Operations
Establishment
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(68634-072) , ANALYSIS(68634-072)

Revised: 4/2021

Document Id: 50ec5b20-8641-4de4-9c19-8e1a4123b2d5

Set id: 131a23ce-ecc6-47db-8bb0-71272c0eacc0

Version: 1

Effective Time: 20210401

AMCOL Health & Beauty Solutions, In