Indications and uses
helps prevent sunburn If used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Safe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen
- Manufacturer
- Emilia Personal Care Inc.
- Effective date
- 2013-11-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:38:04
Label at a glance#
ProductSafe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Children under 6 months: ask a doctor Sun Protection Measures : Spending time in the sun increases your risk of sun 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...
Contacts and useful links#
Websitewww.safeharborsuncare.com
www.safeharborsuncare.com
www.safeharborsuncare.comLabel contents#
Full prescribing information#
Active ingredient
Titanium Dioxide 12.35%
Zinc Oxide 3.5%
Purpose
Sunscreen
Uses
- helps prevent sunburn
- If used as directed with other sun protections 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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use water resistant sunscreen if swimming or sweating
- Children under 6 months: ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of sun 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 10a.m. - 2p.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, cyclopentasiloxane, caprylic/capric triglyceride, C12-15 alkyl benzoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, trimethoxycaprylylsilane, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), butyrospermum parkii (shea butter), persea gratissima (avocado) oil, cananga odorata (ylang-ylang) flower oil, pelargonium graveolens (geranium) flower oil, citrus aurantium bergamia (bergamot) fruit oil, citrus aurantium dulcis (orange) oil, citrus medica limonum (lemon) peel oil, cymbopogon martini (palmarosa) oil, ellettaria cardamomum (cardamon) seed oil, aloe barbadensis leaf juice, allantoin, panthenol (pro-vitamin B5), lecithin, soy isoflavones, polysorbate 80, astaxanthin, bisabolol, hippophae rhamnoides oil, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis (lemon balm) leaf extract, aspalanthus linearis (rooibos) leaf extract
Package/Label Principal Display Panel
Safe Harbor™ Natural Suncare
Free from chemical UV filters
40 Mineral SPF Broad Spectrum Sunscreen
Face & Neck Cream
With Natural Anti-Aging Complex
Moisturizing sunscreen
Anti-aging treatment
rich in age-defying antioxidants
3 Fl. Oz (88.7 mL)
Distributed by: Emilia Personal Care.
Manufactured in Israel.
For more information visit: www.safeharborsuncare.com
UVA, UVB
With Certified Organic Ingredients
Water Resistant
Allergy Tested
ZX41 2E T1
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42421-418-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e13d-f424-e053-dadaa90a57ce | Safe Harbor Natural Suncare |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42421-418-11 | Safe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen | 88.7 mL in 1 TUBE | CREAM | 88.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42421-418 | SAFE HARBOR - NATURAL SUNSCREEN FACE AND NECK CREAM BROAD SPECTRUM SPF40 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EMILIA PERSONAL CARE INC.] | 1 | Legacy NDC, 1 package rows | 20140105_9e2fb9bb-8a79-4675-84df-fd5990f7db1d.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ASPALATHUS LINEARIS LEAF | INACTIVE INGREDIENT | H7UGK1GJCU | 1 | |
| ASTAXANTHIN | INACTIVE INGREDIENT | 8XPW32PR7I | 1 | |
| AVOCADO OIL | INACTIVE INGREDIENT | 6VNO72PFC1 | 1 | |
| BERGAMOT OIL | INACTIVE INGREDIENT | 39W1PKE3JI | 1 | |
| CANANGA OIL | INACTIVE INGREDIENT | 8YOY78GNNX | 1 | |
| CARDAMOM | INACTIVE INGREDIENT | 8BC4CUT4JL | 1 | |
| CETYL DIMETHICONE 150 | INACTIVE INGREDIENT | 5L694Y0T22 | 1 | |
| CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) | INACTIVE INGREDIENT | V2W71V8T0X | 1 | |
| CHAMOMILE | INACTIVE INGREDIENT | FGL3685T2X | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HIPPOPHAE RHAMNOIDES FRUIT OIL | INACTIVE INGREDIENT | TA4JCF9S1J | 1 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| LEMON OIL | INACTIVE INGREDIENT | I9GRO824LL | 1 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 1 | |
| MELISSA OFFICINALIS LEAF | INACTIVE INGREDIENT | 50D2ZE9219 | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| ORANGE OIL | INACTIVE INGREDIENT | AKN3KSD11B | 1 | |
| PALMAROSA OIL | INACTIVE INGREDIENT | 0J3G3O53ST | 1 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 1 | |
| PELARGONIUM GRAVEOLENS FLOWER OIL | INACTIVE INGREDIENT | 3K0J1S7QGC | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SHEANUT OIL | INACTIVE INGREDIENT | O88E196QRF | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SOY ISOFLAVONES | INACTIVE INGREDIENT | 71B37NR06D | 1 | |
| TILIA X EUROPAEA FLOWER | INACTIVE INGREDIENT | NHV2K1OUDH | 1 | |
| TRICAPRYLIN | INACTIVE INGREDIENT | 6P92858988 | 1 | |
| TRIMETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | FZ07E4LW2M | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Safe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen
- Titanium Dioxide, Zinc Oxide
- TITANIUM DIOXIDE
- ZINC OXIDE
- WATER
- CYCLOMETHICONE 5
- TRICAPRYLIN
- ALKYL (C12-15) BENZOATE
- GLYCERIN
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
- CETYL DIMETHICONE 150
- PHENYL TRIMETHICONE
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- TRIMETHOXYCAPRYLYLSILANE
- SODIUM CHLORIDE
- HYDROGENATED CASTOR OIL
- MICROCRYSTALLINE WAX
- .ALPHA.-TOCOPHEROL ACETATE
- SHEANUT OIL
- AVOCADO OIL
- CANANGA OIL
- PELARGONIUM GRAVEOLENS FLOWER OIL
- BERGAMOT OIL
- ORANGE OIL
- LEMON OIL
- PALMAROSA OIL
- CARDAMOM
- ALOE VERA LEAF
- ALLANTOIN
- PANTHENOL
- LECITHIN, SOYBEAN
- SOY ISOFLAVONES
- POLYSORBATE 80
- ASTAXANTHIN
- LEVOMENOL
- HIPPOPHAE RHAMNOIDES FRUIT OIL
- CHAMOMILE
- TILIA X EUROPAEA FLOWER
- MELISSA OFFICINALIS LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42421-418 | 42421-418-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| ALLANTOIN | ALLANTOIN | 344S277G0Z | GEL / TOPICAL | 8 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9e2fb9bb-8a79-4675-84df-fd5990f7db1d | 9e2fb9bb-8a79-4675-84df-fd5990f7db1d | 2013-11-19 | Warnings | 9e2fb9bb-8a79-4675-84df-fd5990f7db1d 9e2fb9bb-8a79-4675-84df-fd5990f7db1d |