FDA.reportPublic FDA data

ANNA LOTAN Rejuvenating Day Cream Broad Spectrum SPF 34

Manufacturer
Anna Lotan Ltd
Effective date
2019-08-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:13:56

Label at a glance#

ProductANNA LOTAN Rejuvenating Day Broad Spectrum SPF 34
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

Helps to 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.

Dosage and administration

Apply Liberally 15 minutes before sun exposure. Reapply: after 40 minutes of swimming or sweating. immediately after towel drying at least every 2 hours. 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 or 15 higher and other protection measures including: Limit time in sun from 10 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Titanium Dioxide 4.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps to 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged / broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. If contact occurs rinse thoroughly with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply Liberally 15 minutes before sun exposure.
  • Reapply: after 40 minutes of swimming or sweating.
  • immediately after towel drying
  • at least every 2 hours.
  • 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 or 15 higher and other protection measures including: Limit time in sun from 10 a.m.-2 p.m.
  • Wear long-sleeve shirts, pants hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Cetearyl Isononanoate, C12-15 Alkyl Benzoate, Simmondsia Chinensis (Jojoba) Seed Oil, Propanediol, Cetearyl Alcohol, Arachidyl Alcohol, Butyrosperum Parkii (Shea Butter), Dipalmitoyl Hydroxyproline, Betaine, Behenyl Alcohol, Glyceryl Stearate, Peg-100 Stearate, Glycine Soja (Soybean) Sterol, Squalane, Dimethicone, Polyacrylate-13, Cetearyl Glucoside, Sclerotium Gum, Triethanolamine, Alumina, Arachidyl Glucoside, Xylitol, Xylitylglucoside, Polyisobutene, Phenoxyethanol, Fragrance, Caprylyl Glycol, Anhydroxylitol, Chlorphenesin, Cetyl Phosphate, Disodium Edta, Simethicone, Polysorbate 20, Tocopherol, Beta-Sitosterol, Squalene.

Questions or Commerce ?

OTC - QUESTIONS SECTION

Questions or Commerce ?

info@annalotan-usa.com Tel:+972 4 6295000

Description

DESCRIPTION SECTION

Product of Israel.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

anna lotan Rejuvenating Day Cream Broad Spectrum SPF 34 2.5 fl oz (75 mL) NEW AGE CONTROL

ANNA LOTAN Rejuvenating Day Cream Broad Spectrum SPF 34 75ml (76446-004-75)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Day CreamDay Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3
OCTINOXATEACTIVE MOIETY4Y5P7MUD513
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3
.BETA.-SITOSTEROLINACTIVE INGREDIENTS347WMO6M43
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333
ANHYDROXYLITOLINACTIVE INGREDIENT8XWR7NN42F3
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BU3
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJ3
BETAINEINACTIVE INGREDIENT3SCV180C9W3
BETASIZOFIRANINACTIVE INGREDIENT2X51AD1X3T3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA3
CETEARYL ISONONANOATEINACTIVE INGREDIENTP5O01U99NI3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S3
CETYL PHOSPHATEINACTIVE INGREDIENTVT07D6X67O3
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
DIPALMITOYL HYDROXYPROLINEINACTIVE INGREDIENTE6AHA53N1H3
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T3
SQUALANEINACTIVE INGREDIENTGW89575KF93
SQUALENEINACTIVE INGREDIENT7QWM220FJH3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P83
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK3
WATERINACTIVE INGREDIENT059QF0KO0R3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E3
XYLITYLGLUCOSIDEINACTIVE INGREDIENTO0IEZ166FB3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76446-00476446-004-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
BETASIZOFIRAN2X51AD1X3TIACT
TROLAMINE9O3K93S3TKIACT
ALUMINUM OXIDELMI26O6933IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
XYLITOLVCQ006KQ1EIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ANHYDROXYLITOL8XWR7NN42FIACT
CHLORPHENESINI670DAL4SZIACT
CETYL PHOSPHATEVT07D6X67OIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 207T1F30V5YHIACT
TOCOPHEROLR0ZB2556P8IACT
.BETA.-SITOSTEROLS347WMO6M4IACT
SQUALENE7QWM220FJHIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPANEDIOL5965N8W85TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DIPALMITOYL HYDROXYPROLINEE6AHA53N1HIACT
BETAINE3SCV180C9WIACT
DOCOSANOL9G1OE216XYIACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 210 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
21 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
DOCOSANOLDOCOSANOL9G1OE216XYAEROSOL, FOAM / TOPICAL1.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCAPSULE / ORAL563 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRABURSAL0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9141a61f-4dcc-0192-e053-2995a90a9a3d0b335648-e24e-41ea-8edf-eed17e67ff252019-08-29WarningsExact identifier
spl id: 9141a61f-4dcc-0192-e053-2995a90a9a3d
spl set id: 0b335648-e24e-41ea-8edf-eed17e67ff25

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.