FDA.reportPublic FDA data

Beauty Lotion SPF 15 909

Manufacturer
American Sales Co | Vi-Jon
Effective date
2020-05-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:30:59

Label at a glance#

ProductComplete Beauty
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun

Dosage and administration

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 highter and other sun protection measures including: limit the time in the sun, e...

Storage and handling

protect the product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.0%

Zinc oxide 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the rise 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 or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 highter and other sun protection measures including:
  • limit the time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect the product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cyclopentasiloxane, cyclohexasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium Herbaceum (cotton) seed oil, behenyl alcohol, cetyl alcohol, DMDM hydantoin, iodopropynyl butylcarbamate, fragrance, tocopheryl acetate, disodium EDTA, steareth-2, oleth-3 phosphate, ascorbic acid, panthenol

SPL UNCLASSIFIED SECTION

Complete Beauty lotion

100% Ainobenzoic Acid (PABA)-Free

Dermatologist Tested

Light, Non-Greast Formula

Non-Comedogenic (Won't Clog Pores)

Broad Spectrum SPF 15 Sunscreen

When used as directed, complete beauty lotion helps provide your skin with broad spectrum protection against prematue skin damage from both UVA and UVB rays to help your skin stay younger looking.

ALL DAY MOISTURE - Formulated with antioxidant Vitamin E plus C and nourishihg beauty moisture that absorbs quickly into skin and lasts all day to help your skin stay soft, smooth and beautiful.

DISTRIBUTED BY:

AMERICAN SALES CO.

4201 WALDEN AVE

LANCASTER, NY 14086

www.care1.info

2012 S+S Brands, Inc

Quality Guaranteed or Your Money Back

909.005/909AE

Principal display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE

complete beauty lotion

UVA and UVB protection plus vitamin E + C

broad spectrum spf 15 sunscreen

4.0 fl oz (118 mL)

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-909-262025-02-20C16284748780-1d6a99b39-8c8c-a426-e053-dadaa90af4c2Beauty Lotion SPF 15 909
41520-909-262022-01-28C16284748780-1d6a99b39-8c8c-a426-e053-dadaa90af4c2Beauty Lotion SPF 15 909

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
ZINC CATIONACTIVE MOIETY13S1S8SF371
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
LAURETH-7INACTIVE INGREDIENTZ95S6G82011
LEVANT COTTONSEED OILINACTIVE INGREDIENTN5CFT140R81
OLETH-3 PHOSPHATEINACTIVE INGREDIENT8Q0Z18J1VL1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PEG/PPG-20/20 DIMETHICONEINACTIVE INGREDIENTBA94B7CK8K1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZX1
STEARETH-2INACTIVE INGREDIENTV56DFE46J51
STEARETH-21INACTIVE INGREDIENT53J3F32P581
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-90941520-909-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
POLYSORBATE 806OZP39ZG8HIACT
LAURETH-7Z95S6G8201IACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PEG/PPG-20/20 DIMETHICONEBA94B7CK8KIACT
STEARETH-2153J3F32P58IACT
STEARYL ALCOHOL2KR89I4H1YIACT
LEVANT COTTONSEED OILN5CFT140R8IACT
DOCOSANOL9G1OE216XYIACT
CETYL ALCOHOL936JST6JCNIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
STEARETH-2V56DFE46J5IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
PANTHENOLWV9CM0O67ZIACT

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 6 · 302 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.11 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
STEARETH-2STEARETH-2V56DFE46J5AEROSOL, FOAM / TOPICAL1.09 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RPOWDER, FOR SOLUTION / ORAL560 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / ORAL600 mgExact identifier — unii candidate
25 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / VAGINAL425 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPASTE / ORAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, ORALLY DISINTEGRATING / ORAL2.35 mgExact identifier — unii candidate
25 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 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
2e94a827-737a-1890-e063-6294a90a0d27d2fed288-9be8-4bd2-abe6-9109cead91e12025-02-20WarningsExact identifier
spl set id: d2fed288-9be8-4bd2-abe6-9109cead91e1

Reported adverse events (FAERS/openFDA)#

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