ANNA LOTAN LIGHTLY TINTED MINERAL DAY CREAM BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide cream

Anna Lotan Lightly Tinted Mineral Day Cream Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Anna Lotan Lightly Tinted Mineral Day Cream Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 7.75%
Zinc Oxide 10.0%

Purpose:

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protective 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.

Directions

apply to all skin exposed to the sun
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use water resistant sunscreen if swimming or sweating 
for 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 value of 15 or higher and other sun protection measures including:    
    limit time in sun from 10 a.m.- 2 p.m.    
    wear long-sleeved shirts, pants, hats and sunglasses

Other information

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

Inactive ingredients

water (aqua), caprylic/capric triglyceride, butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, aluminum stearate, carthamus tinctorius oleosomes, polyhydroxystearic acid, aloe barbadensis leaf juice, polygonum aviculare extract, tocopheryl acetate, perilla frutescens extract, vitis vinifera fruit cell extract, lepidium sativum sprout extract, squalane, cetearyl alcohol, isononyl isononanoate, coco-glucoside, pentylene glycol, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, simmondsia chinensis (jojoba) seed oil, stearic acid, sucrose stearate, phenethyl alcohol, tetrahexyldecyl ascorbate, glyceryl caprylate, ethylene/propylene/styrene copolymer, sorbitan oleate, polyglyceryl-2 caprate, propanediol, alumina, arachidyl alcohol, iron oxides (CI 77492, CI 77491, CI 77499).

Questions or Comments?

(781) 281-0954

SPL UNCLASSIFIED SECTION

For all skin types

This lightly tinted daytime moisturizer provides broad spectrum protection based on minerals alone excluding chemical absorbers.

The formula is enriched with skin friendly, sustainable emollients which are easily absorbed by the skin while minimizing the white appearance common to mineral based sunscreens.

A wide range of free radical scavengers provides the antioxidant protection which is vital during exposure to UV light.

Vitamin E supported by a stable ester form of Vitamin C protects the skin’s own lipids as well as the seed oils in the formula.

Extracts of Garden Cress sprouts and Grapes contribute their antioxidants to the water based part of the composition.

Distributed by: Anna Lotan USA Inc.
16 Wheeling Ave, Woburn, MA 01801

www.annalotanusa.com
info@annalotanusa.com

Packaging

INGREDIENTS AND APPEARANCE

ANNA LOTAN LIGHTLY TINTED MINERAL DAY CREAM BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA)
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
SQUALANE (UNII: GW89575KF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
COCO GLUCOSIDE (UNII: ICS790225B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DOCOSANOL (UNII: 9G1OE216XY)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE STEARATE (UNII: 274KW0O50M)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)
PROPANEDIOL (UNII: 5965N8W85T)
ALUMINUM OXIDE (UNII: LMI26O6933)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-300-50	1 in 1 CARTON	05/25/2022
1		50 mL in 1 BOTTLE, PUMP; 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	05/25/2022

Labeler - Anna Lotan Ltd (600458368)